[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"motor-neuron-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:motor-neuron-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,47,83,105,146,168,191,221,268,295,328,351,384,430,454,474,495,512,543,568,592,621,649,669],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100201553","electrical-impedance-myography-natural-history-studies-inneuromuscular-disorders-and-healthy-volunteers-100201553",false,"NCT01900132","Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers","Electrical Impedance Myography: Natural History Studies in Neuromuscular Disorders and Healthy Volunteers","* INCLUSION CRITERIA:\n\nHEALTHY VOLUNTEERS-ADULTS\n\n1. Healthy adults, male or female, aged 18 years old or older,\n2. In good general health as evidenced by medical history\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nHEALTHY VOLUNTEERS-PEDIATRIC\n\n1. Healthy children, male or female, age 7-18,\n2. In good general health as evidenced by medical history\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Ability of subject or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nSUBJECTS WITH NEUROMUSCULAR DISEASE\n\nAdult and pediatric, male or female, patients with a neuromuscular disorder are eligible even if the exact etiology of the disorder is unknown at the time of enrollment into this study. This will include neuropathy, myopathy and motor neuron disorders. It is expected that the subjects are undergoing appropriate standard diagnostic and genetic work-up outside of this protocol that will later clarify the specific etiology of the disorder. Movement disorder will also be included because of the prior research done on dystonia and EIM.\n\nInclusion criteria\n\n1. Suspected motor neuron disease or\n2. Suspected myopathy or\n3. Suspected neuropathy or\n4. Suspected movement disorders that impair intracortical processes\n5. Age of 2 years or older\n6. Ability of subject to sign a written informed consent document.\n\nNIH EMPLOYEES:\n\nNIH employees and staff may participate, however EMG Section, OCD, NINDS, employees may not participate.\n\nEXCLUSION CRITERIA:\n\nHEALTHY VOLUNTEERS-ADULTS\n\n1. Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.\n2. History of stroke, muscle disorders, peripheral neuropathy or spine surgery\n\nHEALTHY VOLUNTEERS-PEDIATRIC\n\n1. Medical conditions that require medications that affects the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.\n2. History of stroke, muscle disorders, peripheral neuropathy or spine surgery\n\nSUBJECTS WITH NEUROMUSCULAR DISEASE:\n\nNo clinical evidence of a neuromuscular disorder on clinical evaluation.",true,"ALL","2 Years","110 Years",{"count":21,"type":22},275,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background:\n\n\\- Electrical impedance myography (EIM) is a new technique being studied to see if it is helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless electrical current travels through muscles. Researchers want to gain experience in using the EIM device. They will collect information on the results of using it on people with and without nerve and muscle diseases, and compare that with information from other standard tests. First, they will test the device on healthy people. Then they will test people with a variety of neuromuscular diseases. Because the test is noninvasive and not painful, researchers will test both children and adults.\n\nObjectives:\n\n\\- To gain experience using the EIM muscle testing device.\n\nEligibility:\n\n* Healthy volunteers at least 2 years old.\n* Individuals at least 2 years old who have neuromuscular disease.\n\nDesign:\n\n* Participants will be screened with a medical history and physical exam.\n* Participants will have one 2-3 hour clinic visit. Researchers may request follow-up visits.\n* Participants will be tested with the EIM device. The device and small electrodes will be placed on their skin. An electric current will pass through the device, but the participants will not feel this.\n* Participants may have an ultrasound test. A gel will be put on their skin, and a device will be moved over the skin.\n* Participants may have a nerve test. Electrodes will be placed on their skin, and they will feel a small shock.\n* Participants may have a test where a thin needle is inserted in their muscle.",[28,29,30,31],"Neuromuscular Disease","Motor Neuron Disease","Inherited Neuromuscular Conditions","Inherited Neuropathies",[33,28],"Electrophysiology","RECRUITING","2026-06-23",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2013-06-20",{"date":42,"type":22},"2027-06-01",{"name":44,"class":45},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":52,"conditions":59,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":46},"100633993","functional-outcomes-and-control-using-synchron-bci---australia-100633993","NCT07533903","Functional Outcomes and Control Using Synchron BCI - Australia","Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)","FOCUS-AUS","Inclusion Criteria:\n\n1. Able to provide informed consent to participate in the study.\n2. Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis\n3. The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.\n4. Aged 21 years or older\n5. Life expectancy greater than 12 months post-implantation\n6. Preserved precentral gyrus assessed using CT\n7. Suitable vascular anatomy assessed using CT venography\n8. Suitable anatomy for subcutaneous pocket creation\n9. Able to undergo anesthesia\n10. Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.\n11. Caregiver(s) willing and able to facilitate study visits, including visits at the study site and in the home, and BCI use outside of study visits (e.g. device charging)\n12. Patient and caregiver fluent in English\n13. Suitable home environment for BCI training, including an internet connection\n\nExclusion Criteria:\n\n1. Unrealistic expectations regarding the potential benefits of the device.\n2. Active infection or unexplained fever in the 48 hours prior to informed consent\n3. Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.\n4. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.\n5. Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).\n6. Known allergy to patient-contacting materials included in the implanted device\n7. Contraindication to angiographic imaging or iodine contrast media.\n8. History of central venous sinus thrombosis.\n9. Recent history of new venous thromboembolic event (in the 6 months prior to implant) or recurrent history of venous thromboembolic disease\n10. Contraindication to antithrombotic therapy.\n11. Participant is at substantially increased risk of infection, including immunocompromised status, recurrent infection, or poorly controlled diabetes mellitus.\n12. Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.\n13. Pregnant or breast feeding.\n14. Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.\n15. Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.","21 Years",{"count":57,"type":22},10,[25],[60,61,62,29,63,64,65],"Neurologic Disorder","Neurologic Diseases","MND (Motor Neurone DIsease)","Motor Neuron Disease, Amyotrophic Lateral Sclerosis","Paralysis Arm","Paralysis",[67,68,69,70,71,72],"ALS","BCI","Brain Computer Interface","MND","Upper Limb Paralysis","Motor Neurone Disease","2026-06-05",{"date":75,"type":38},"2026-06-09",{"date":77,"type":38},"2026-05-22",{"date":79,"type":22},"2027-12",{"name":81,"class":82},"Synchron, Inc.","INDUSTRY",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":87,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100634721","independence-through-endovascular-neuroprosthetic-technology-intent-an-early-feasibility-study-100634721","NCT07543367","INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study","Inclusion Criteria:\n\n* Able to provide informed consent to participate in the study.\n* Diagnosis of ALS, with bilateral upper-limb paresis.\n* ALS must be refractory to treatment and have been present for a minimum of six months.\n* Aged 22 years or older.\n* Life expectancy greater than 12 months post-implantation.\n* Preserved precentral gyrus assessed using CT.\n* Suitable vascular anatomy assessed using CT venography.\n* Suitable anatomy for subcutaneous pocket creation.\n* Able to undergo anesthesia.\n* Willing and able to comply with all investigational requirements, including clinical testing visits and training visits in the home.\n* Caregiver(s) willing and able to facilitate study visits, including visits to the study site and in the home, and BCI use outside of study visits (e.g., device charging).\n* Patient and caregiver fluent in English.\n* Suitable home environment for BCI training.\n\nExclusion Criteria:\n\n* Active infection or unexplained fever in the 48 hours prior to informed consent.\n* Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.\n* Diagnosis of ALS-FTD or another dementia.\n* Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).\n* Known allergy to patient-contacting materials included in the implanted device.\n* Contraindication to angiographic imaging or iodine contrast media.\n* History of central venous sinus thrombosis.\n* Recent history of new venous thromboembolic event (in the 6 months prior to implant), recurrent history of venous thromboembolic disease, or hypercoagulable state.\n* Contraindication to antithrombotic therapy.\n* Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.\n* Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.\n* Pregnant or breast feeding.\n* Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.\n* Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.","22 Years",{"count":57,"type":22},[25],[93,94,29,95,67],"Neurological Disorder","ALS (Amyotrophic Lateral Sclerosis)","ALS - Amyotrophic Lateral Sclerosis","2026-05-07",{"date":98,"type":38},"2026-05-11",{"date":100,"type":22},"2026-04",{"date":102,"type":22},"2029-12",{"name":81,"class":82},5,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":16,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":127,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":46},"100453331","non-invasive-bci-controlled-assistive-devices-100453331","NCT05183152","Non-invasive BCI-controlled Assistive Devices","Non-invasive Brain-computer Interfaces for Control of Assistive Devices","Inclusion Criteria:\n\n1. Able-bodied participants:\n\n   * good general health\n   * normal or corrected vision\n   * no history of neurological\u002Fpsychiatric disease\n   * ability to read and understand English (Research Personnel do not speak Spanish)\n2. Subjects with motor disabilities\n\n   * motor deficits due to: unilateral and bilateral stroke \u002F spinal cord injury \u002F motor neuron diseases (i.e. amyotrophic lateral sclerosis, spino-cerebellar ataxia, multiple sclerosis) \u002F muscular diseases (i.e. myopathy) \u002F traumatic or neurological pain \u002F movement disorders (i.e. cerebral palsy) \u002F orthopedic \u002F traumatic brain injury \u002F brain tumors\n   * normal or corrected vision\n   * ability to read and understand English\n   * ability to provide informed consent\n\nExclusion Criteria:\n\n1. Subjects with motor disabilities\n\n   * short attentional spans or cognitive deficits that prevent the subject from concentrating during the whole experimental session\n   * heavy medication affecting the central nervous system (including vigilance)\n   * concomitant serious illness (e.g., metabolic disorders)\n2. All participants\n\n   * factors hindering EEG\u002FEMG acquisition and the delivery of non-invasive electrical stimulation (e.g., skin infection, wounds, dermatitis, metal implants under electrodes)\n   * criteria identified in safety guidelines for MRI and TMS, in particular metallic implants","18 Years","80 Years",{"count":115,"type":22},100,[25],"Injuries affecting the central nervous system may disrupt the cortical pathways to muscles causing loss of motor control. Nevertheless, the brain still exhibits sensorimotor rhythms (SMRs) during movement intents or motor imagery (MI), which is the mental rehearsal of the kinesthetics of a movement without actually performing it. Brain-computer interfaces (BCIs) can decode SMRs to control assistive devices and promote functional recovery. Despite rapid advancements in non-invasive BCI systems based on EEG, two persistent challenges remain: First, the instability of SMR patterns due to the non-stationarity of neural signals, which may significantly degrade BCI performance over days and hamper the effectiveness of BCI-based rehabilitation. Second, differentiating MI patterns corresponding to fine hand movements of the same limb is still difficult due to the low spatial resolution of EEG. To address the first challenge, subjects usually learn to elicit reliable SMR and improve BCI control through longitudinal training, so a fundamental question is how to accelerate subject training building upon the SMR neurophysiology. In this study, the investigators hypothesize that conditioning the brain with transcutaneous electrical spinal stimulation, which reportedly induces cortical inhibition, would constrain the neural dynamics and promote focal and strong SMR modulations in subsequent MI-based BCI training sessions - leading to accelerated BCI training. To address the second challenge, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to the voluntary activation of the primary motor cortex through MI can help differentiate patterns of activity associated with different hand movements of the same limb by consistently recruiting the separate neural pathways associated with each of the movements within a closed-loop BCI setup. The investigators study the neuroplastic changes associated with training with the two stimulation modalities.",[119,120,121,122,29,123,124,125,126],"Motor Disorders","Healthy","Spinal Cord Injuries","Muscular Diseases","Stroke","Traumatic Brain Injury","Movement Disorders","Multiple Sclerosis",[128,129,130,131,132,133,134,135],"motor deficits","able-bodied, healthy","unilateral and bilateral stroke","spinal cord injury","motor neuron diseases","muscular diseases (i.e. myopathy)","traumatic or neurological pain","movement disorders","2026-04-27",{"date":138,"type":38},"2026-05-01",{"date":140,"type":38},"2021-06-16",{"date":142,"type":22},"2028-12-30",{"name":144,"class":145},"University of Texas at Austin","OTHER",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100627244","functional-outcomes-and-control-using-synchron-bci---canada-100627244","NCT07446114","Functional Outcomes and Control Using Synchron BCI - Canada","FOCUS-CAN","INCLUSION CRITERIA:\n\n1. Able to provide informed consent to participate in the study, in the opinion of the Investigator(s).\n2. Diagnosis of amyotrophic lateral sclerosis or motor neuron disease, with bilateral upper-limb paresis.\n3. Aged 18 years or older.\n4. Life expectancy greater than 12 months post-implantation, in the opinion of the Investigator(s).\n5. Preserved precentral gyrus assessed using CT.\n6. Suitable vascular anatomy, in the opinion of the Investigator(s), assessed using CT venography.\n7. Suitable anatomy for subcutaneous pocket creation.\n8. Able to undergo anesthesia.\n9. Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.\n10. Caregiver(s) willing and able to facilitate study visits, including visits at the study site and in the home, and BCI use outside of study visits (e.g., device charging).\n11. Patient and Caregiver fluent in English.\n12. Suitable home environment for BCI training, including an internet connection.\n\nEXCLUSION CRITERIA:\n\n1. Unrealistic expectations regarding the potential benefits of the device, in the opinion of the Investigator(s).\n2. Active infection or unexplained fever in the 48 hours prior to informed consent.\n3. Major psychiatric disorder that may adversely impact the participant's safety or study compliance (e.g., severe depression, psychotic features, personality disorder, severe emotional lability, substance abuse), in the opinion of the Investigator(s).\n4. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities, in the opinion of the Investigator(s).\n5. Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).\n6. Known allergy to patient-contacting materials included in the implanted device (listed in Physician Implant Manual).\n7. Contraindication to angiographic imaging or iodine contrast media.\n8. History of central venous sinus thrombosis.\n9. Recent history of new venous thromboembolic event (in the 6 months prior to implant) or recurrent history of venous thromboembolic disease.\n10. Contraindication to antithrombotic therapy, in the opinion of the Investigator(s).\n11. Participant is at substantially increased risk of infection, including immunocompromised status, recurrent or chronic infection, or poorly controlled diabetes mellitus.\n12. Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.\n13. Currently receiving or expected to require medical treatment that may be precluded by device implant, including magnetic resonance imaging, transcranial magnetic stimulation, electroconvulsive therapy, transcranial ultrasound, shortwave, microwave, and\u002For therapeutic ultrasound diathermy, or balloon angioplasty or stenting in the target vessel.\n14. Pregnant or breast feeding.\n15. Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.\n16. Patients with ALS due to SOD1 mutations on gene therapy.\n17. Any other disease or disorder that could significantly affect participation in the study, in the opinion of the Investigator(s). Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.",{"count":57,"type":22},[25],"Functional Outcomes and Control Using Synchron BCI - Canada (FOCUS-CAN)",[60,67,29],[67,68,158,70,29],"Brain computer interface","2026-04-14",{"date":161,"type":38},"2026-04-17",{"date":163,"type":38},"2026-03-18",{"date":165,"type":22},"2027-07",{"name":81,"class":82},2,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":4,"leadSponsor":190,"locationsCount":167},"100057066","study-of-inherited-neurological-disorders-100057066","NCT00004568","Study of Inherited Neurological Disorders","Clinical and Molecular Manifestations of Inherited Neurological Disorders","* Participants include those with inherited neurological conditions based on the training and research needs of the Neurogenetics Branch program. There is no logical limit; however the total number of participants that can be enrolled in the protocol will be restricted. No more than 3,500 participants with either diagnosed or undiagnosed neurological conditions and their unaffected relatives will be enrolled in this evaluation and diagnostic protocol.\n\nINCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n* Have either a known or suspected, inherited neurological disease, OR are an unaffected relative (first-, second-, third, or higher degree relative) of a participant with a genetic neurological disease.\n* Have the ability to understand and sign an informed consent or have a parent\u002Flegal guardian to do so if they are minor children or a legal guardian to provide consent for adults without consent capacity.\n* Aged 2 years and above.\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n-Have a systemic disease that compromises the ability to provide adequate neurologic examination or diagnosis.An example of this would be a contagious disease that would compromise our ability to do an adequate neurological exam.","120 Years",{"count":177,"type":22},3500,"OBSERVATIONAL","This study is designed to learn more about the natural history of inherited neurological disorders and the role of heredity in their development. It will examine the genetics, symptoms, disease progression, treatment, and psychological and behavioral impact of diseases in the following categories: hereditary peripheral neuropathies; hereditary myopathies; muscular dystrophies; hereditary motor neuron disorders; mitochondrial myopathies; hereditary neurocognitive disorders; inherited neurological disorders without known diagnosis; and others. Many of these diseases, which affect the brain, spinal cord, muscles, and nerves, are rare and poorly understood.\n\nChildren and adults of all ages with various inherited neurological disorders may be eligible for this study. Participants will undergo a detailed medical and family history, and a family tree will be drawn. They will also have a physical and neurological examination that may include blood test and urine tests, an EEG (brain wave recordings), psychological tests, and speech and language and rehabilitation evaluations. A blood sample or skin biopsy may be taken for genetic testing. Depending on the individual patient s symptoms, imaging tests such as X-rays, CT or MRI scans and muscle and nerve testing may also be done.\n\nInformation from this study may provide a better understanding of the genetic underpinnings of these disorders, contributing to improved diagnosis, treatment, and genetic counseling, and perhaps leading to additional studies in these areas.",[29,181,182,183],"Muscular Disease","Muscular Dystrophy","Peripheral Nervous System Disease",[185,182,29],"Myopathy","2026-04-11",{"date":159,"type":38},{"date":189,"type":38},"2000-02-18",{"name":44,"class":45},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":46},"100630731","impact-of-physical-functioning-on-patient-reported-outcomes-in-als-patients-at-tidalhealth-100630731","NCT07491484","Impact of Physical Functioning on Patient-Reported Outcomes in ALS Patients at TidalHealth","The Impact of Physical Functioning on Self-Reported Measures of Quality of Life in the ALS Patient Population at TidalHealth Peninsula Regional","ALS QoL","Inclusion Criteria:\n\n* Over the age of 18\n* Have a diagnosis of Amyotrophic Lateral Sclerosis of Motor Neuron Disease\n* Able to comprehend and willing to sign an informed consent form and comply with study procedures.\n* Receiving care at TidalHealth Peninsula Regional Multidisciplinary ALS Clinic\n\nExclusion Criteria:\n\n* Unable to read and understand English\n* Unwilling or unable to comply with the study procedure, including the presence of any condition that is likely to affect the participant's ability to comply with study procedures.",{"count":200,"type":22},30,"Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disease in which motor neuron cells of the brain and spinal cord progressively degenerate and die. There is currently a lack of curative treatment for individuals that are diagnosed with ALS. Since treatment options are limited, researchers have placed greater emphasis on evaluating Quality-of-Life (QoL) as it offers perspective into the everyday life of the patient and is sensitive to changes over time.\n\nThe goal of this longitudinal observational study is to learn more about what factors negatively impact an individual's QoL after they are diagnosed with ALS. Previous research has shown that an individual's level of physical functioning can negatively impact their quality of life, but this may not be the only factor.\n\nThe main objectives this study are:\n\n1. Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).\n2. Determine how disease stage (King's Clinical Severity Staging System) affects correlation between functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).\n\nParticipants will complete a quality-of-life questionnaire (ALSAQ-40) every other time they present to their standard-of-care clinic visits for a period of two years. In parallel, with the functionality rating (ALSFRS-R) scores captured as standard-of-care at every clinic visit.",[203,29],"Amyotrophic Lateral Sclerosis",[205,206,207,208,209,210,211,212,203,67,29,70],"Quality of Life","ALSAQ-40","ALSFRS-R","Physical Functioning","Patient Reported Outcomes","PRO","King's Clinical Severity Staging System","QoL","2026-03-19",{"date":215,"type":38},"2026-03-24",{"date":217,"type":38},"2025-07-03",{"date":165,"type":22},{"name":220,"class":145},"TidalHealth, Inc.",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":232,"studyType":178,"phases":4,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":46},"100466506","hereditary-spastic-paraplegia-genomic-sequencing-initiative-hspseq-100466506","NCT05354622","Hereditary Spastic Paraplegia Genomic Sequencing Initiative (HSPseq)","Investigating the Genetic Basis of Hereditary Spastic Paraplegia","Inclusion Criteria:\n\n* Clinical diagnosis of progressive spasticity","1 Month","30 Years",{"count":231,"type":22},200,"5 Years","The purpose of the HSP Sequencing Initiative is to better understand the role of genetics in hereditary spastic paraplegia (HSP) and related disorders. The HSPs are a group of more than 80 inherited neurological diseases that share the common feature of progressive spasticity. Collectively, the HSPs present the most common cause of inherited spasticity and associated disability, with a combined prevalence of 2-5 cases per 100,000 individuals worldwide.\n\nIn childhood-onset forms, initial symptoms are often non-specific and many children may not receive a diagnosis until progressive features are recognized, often leading to a significant diagnostic delay. Genetic testing in children with spastic paraplegia is not yet standard practice. In this study, the investigators hope to identify genetic factors related to HSP. By identifying different genetic factors, the investigators hope that over time we can develop better treatments for sub-categories of HSP based on cause.",[235,236,237,238,29,125],"Hereditary Spastic Paraplegia","Neurodegenerative Diseases","Pediatric Disorder","Spasticity, Muscle",[235,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259],"Neurodegenerative disease","Spasticity","SPG3a","SPG4","SPG11","SPG15","SPG26","SPG47","SPG50","SPG51","SPG52","Complex hereditary spastic paraplegia","Early Onset hereditary spastic paraplegia","Movement disorder","Adaptor protein complex 4","Neurogenetic disorder","Genetic Disease","Muscle Spasticity","Neurodevelopmental disorders","Musculoskeletal Disease","2026-03-16",{"date":163,"type":38},{"date":263,"type":38},"2022-04-25",{"date":265,"type":22},"2027-04-29",{"name":267,"class":145},"Boston Children's Hospital",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":16,"sex":275,"minAge":112,"maxAge":175,"enrollmentInfo":276,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":46},"100435033","clinical-molecular-and-imaging-biomarkers-in-spinal-and-bulbar-muscular-atrophy-sbma-100435033","NCT04944940","Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)","An Observational Study to Assess Clinical, Molecular and Imaging Biomarkers in Spinal and Bulbar Muscular Atrophy (SBMA)","* INCLUSION CRITERIA:\n\nSome restrictions are placed on participation in the study because we aim to identify disease biomarkers specific to those with early to intermediate stages of disease who would be potential candidates for future therapeutic studies.\n\nIn order to be eligible to participate in the SBMA cohort, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male, above the age of 18 years\n* Genetically confirmed SBMA\n* Ability of subject to understand and the willingness to sign a written informed consent document\n* Ability of subject to travel to the NIH Clinical Center.\n\nNote: an SBMA patient who meets both of the additional following criteria will be offered an optional whole body MRI at subsequent follow-up visits:\n\n* Spinal bulbar muscular atrophy functional rating of \\\u003C 50 (and \\> 35).\n* On initial whole body MRI, subject has evidence of muscle fat replacement such that the total volume of disease affected muscles (i.e., muscles with at least 10% muscle fat infiltration and no more than 50% muscle fat fraction) is at least:\n\n  * 500ml if only 1 muscle is eligible or\n  * 250ml if more than one muscle meets the criteria\n\nIn order to be eligible to participate in this study in the Healthy Control cohort, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability to travel to the NIH for the duration of the study\n* Male, above the age of 18 years\n* No history of SBMA or other neuromuscular disorder\n* No history of facial palsy\n* Ability of subject to understand and the willingness to sign a written informed consent document\n* Ability of subject to travel to the NIH Clinical Center.\n\nEXCLUSION CRITERIA:\n\nSBMA is a disease that affects males and manifests in adulthood. Thus, woman and children are not included in this study. This study will not include individuals who lack consent capacity.\n\nAn SBMA patient who meets any of the following criteria will be excluded from participation in this study:\n\n* Contraindications to MRI such as a contraindicated non-removable metal device (i.e., pacemaker, defibrillator, insulin pump, metal clips, non-removable jewelry) or claustrophobia.\n* Non ambulatory\n* Use of androgen reducing agents within the past two years\n\nNote: An SBMA patient who meets any of the following criteria will be excluded from the lumbar puncture procedure:\n\n* PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\\u003C70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants\n\nNote: An SBMA patient who meets any of the following criteria will be excluded from the muscle biopsy procedure:\n\n* Advanced wasting of tibialis anterior that precludes needle muscle biopsy (in order to ensure that a sample taken would be of muscle and not just fat and fascia)\n* Use of aspirin or non-steroidal anti-inflammatory agents 3 days prior to the procedure\n\nNote: An SBMA patient who meets any of the following criteria will be excluded from the whole body MRI:\n\n* Patient has a history of prior treatment with androgen reducing agents including LHRH agonists or antagonists, androgen receptor antagonists and selective androgen receptor modifiers.\n* Patient is unable to complete the study assessments of QMT or timed walk tests.\n* Patient anticipates making major lifestyle changes during the observation period relating to diet and exercise.\n\nA Healthy Control participant who meets any of the following criteria will be excluded from the study:\n\n* PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\\u003C70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants","MALE",{"count":277,"type":22},70,"Background:\n\nSBMA is an inherited chronic disease. It affects males in mid to late adulthood. It causes slowly progressive weakness of muscles and hand tremors. Researchers want to learn more about the effects of SBMA.\n\nObjective:\n\nTo identify measurements that change over time in SBMA, including tests of muscle strength and function, as well as measurements of muscle and fat size.\n\nEligibility:\n\nMen over the age of 18 both with and without a history of SBMA.\n\nDesign:\n\nParticipants will have a medical history, physical exam, and blood and urine tests. They will have neuromuscular ultrasound. They will have a lumbar puncture to obtain spinal fluid. For this, a needle will be inserted into the spinal canal in the lower back.\n\nParticipants will have muscle strength and function tests. These tests may include pushing, pulling, rising from a chair and sitting back down, and\u002For walking. During these tests, they may wear an accelerometer (activity tracker) on their wrist.\n\nParticipants will get an activity tracker to wear on their wrist for 10 days at home every 3 months.\n\nParticipants with SBMA will also have lower limb magnetic resonance imaging (MRI) and optional whole-body MRI. They will have lung function tests. They will have speech and swallow tests. They will complete questionnaires. They may have optional body scans to measure bone density and lean body mass. They may have optional muscle biopsies. For biopsies, a needle will be used to take a small piece of muscle from the leg.\n\nParticipants with SBMA will have 5 study visits over 2 years (every 6 months). Participants without SBMA will have 1 study visit.",[280,281,29],"Spinal and Bulbar Muscular Atrophy","Kennedys Disease",[29,280,283,284,285,286],"Kennedys disease","Androgen Receptor","Natural History Study","Natural History","2026-03-10",{"date":289,"type":38},"2026-03-11",{"date":291,"type":38},"2021-10-25",{"date":293,"type":22},"2027-02-28",{"name":44,"class":45},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":16,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":303,"targetDuration":232,"studyType":178,"phases":4,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100449836","target-als-biomarker-study-longitudinal-biofluids-clinical-measures-and-at-home-measures-100449836","NCT05137665","Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures","Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures","TALSLB","ALS Participants:\n\n1. Age 18 or older.\n2. A diagnosis of ALS in accordance with Gold Coast criteria.\n3. Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening.\n4. Ability to provide informed consent and understand the purpose and risks of the study.\n5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.\n\nHealthy Control Participants:\n\n1. Age 18 or older.\n2. No history of neurological disease, in the opinion of the Principal Investigator.\n3. No known ALS- associated genetic mutations at the time of consent.\n4. Ability to provide informed consent and understand the purpose and risks of the study.\n5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.",{"count":304,"type":22},1000,"The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.",[203,125,307,29],"Degenerative Disorder",[203,309,310,311,312,313,314,315,316,317],"ALS Amyotrophic Lateral Sclerosis","Target ALS","Longitudinal Biofluids","Barrow Neurological Institute","New York Genome Center","Biofluids Biorepository","Genomic-wide association studies","observational study","Biofluid Samples","2025-11-20",{"date":320,"type":38},"2025-11-21",{"date":322,"type":38},"2021-06-01",{"date":324,"type":22},"2031-12-31",{"name":326,"class":145},"Target ALS Foundation, Inc.",12,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":16,"sex":17,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":46},"100550695","digital-app-for-speech--health-monitoring-100550695","NCT06450418","Digital App for Speech & Health Monitoring","Digital App for Speech & Health Monitoring in Neurodegenerative Disorders","Inclusion Criteria - Any one of the following:\n\n* A person with a diagnosis of Motor Neuron Disease, Dementia, Multiple Sclerosis, or Parkinson's Disease.\n* A relative or carer of the above who does not report to have a neurological condition.\n* A healthy volunteer who does not report to have a neurological condition.\n\nExclusion Criteria:\n\n* Age \\\u003C16 years\n* Significant and uncorrected visual or hearing impairment (precluding use of the App).\n* Lack capacity to consent to project due to cognitive impairment (precluding understanding of the study and use of the App).","16 Years",{"count":337,"type":22},150,"Many people living with neurodegenerative conditions like dementia, motor neuron disease (MND), multiple sclerosis (MS), and Parkinson's disease (PD), suffer from speech problems. Using common digital technologies such as smartphone apps, the investigators can record and analyse speech in detail to provide new information for people living with these conditions, researchers, and healthcare professionals. This study will investigate the use of these digital speech recordings to help diagnose and monitor these conditions.\n\nTo take part, participants will have either a diagnosis of dementia, motor neuron disease, Parkinson's disease or Multiple Sclerosis, OR they will have no diagnosis of a neurological condition. Researchers will compare people with a diagnosis of a Neurological condition to those without.",[340,29,126,341],"Dementia","Parkinson Disease","2025-09-17",{"date":344,"type":38},"2025-09-18",{"date":346,"type":38},"2024-07-12",{"date":348,"type":22},"2026-06",{"name":350,"class":145},"University of Edinburgh",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":16,"sex":17,"minAge":358,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":366,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100496444","effects-of-long-term-ventilation-support-on-the-quality-of-life-of-als-patients-and-their-families-100496444","NCT05744310","Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families","ALS-LTMV","Inclusion criteria for patients:\n\n1. A clinical diagnosis of probable ALS according to the revised El Escorial criteria\n2. Progression of the illness leading the consulting physician to offer treatment with LTMV\n3. Can communicate in Norwegian\n\nInclusion criteria for partners of ALS patients:\n\n1. Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nInclusion criteria for children:\n\n1. Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nExclusion criteria for patients, partners and children of ALS patients:\n\n1\\. Potential participants with cognitive impairment or dementia.","8 Years",{"count":231,"type":22},[25],"Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality.\n\nThe present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.",[203,29,363,364,236,365],"Nervous System Diseases","Spinal Cord Diseases","TDP-43 Proteinopathies",[367,368,369,370,371,372,373],"Quality of life","Overall quality of life","Health related quality of life","Disease specific quality of life","Ventilation support","Non-invasive ventilation support","Invasive ventilation support","2025-08-22",{"date":376,"type":38},"2025-08-28",{"date":378,"type":38},"2023-04-21",{"date":380,"type":22},"2032-08-21",{"name":382,"class":145},"Haukeland University Hospital",9,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":404,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":167},"100602719","gb-prime-an-early-feasibility-study-of-a-precise-robotically-implanted-brain-computer-interface-for-the-control-of-external-devices-100602719","NCT07127172","GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","GB-PRIME","Inclusion Criteria:\n\n* (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.\n\nOR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.\n\n* Life expectancy ≥ 12 months.\n* Ability to communicate in English\n* Presence of a stable caregiver\n\nExclusion Criteria:\n\n* Moderate to high risk for serious perioperative adverse events\n* Active implanted devices\n* Morbid obesity (Body Mass Index \\> 40)\n* History of poorly controlled seizures or epilepsy\n* History of poorly controlled diabetes\n* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions\n* Acquired or hereditary immunosuppression\n* Use of smoking tobacco or other tobacco products\n* Psychiatric or psychological disorder\n* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.\n* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure",{"count":392,"type":22},7,[25],"The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.\n\nThe N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.",[396,397,398,399,400,401,402,29,403],"Tetraplegia\u002FTetraparesis","Quadriplegia","Quadriplegia\u002FTetraplegia","Cervical Spinal Cord Injury","Amyotrophic Lateral Sclerosis (ALS)","Spinal Cord Injury (Quadraplegia)","Spinal Cord Injury","Brain Stem Stroke",[405,406,407,408,409,410,411,67,131,412,413,414,415,416,417,418,419,420],"brain computer interface","Neuralink N1 Implant","Neuralink","Robot","tetraparesis","tetraplegia","quadriplegia","Amyotrophic lateral sclerosis","chip","brain chip","External device control","Wireless implant","Neuroprosthetics","SCI","paralysis","motor neuron disease","2025-08-11",{"date":423,"type":38},"2025-08-17",{"date":425,"type":38},"2025-07-31",{"date":427,"type":22},"2031-02",{"name":429,"class":82},"Neuralink Corp",{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":438,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":444,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":167},"100600113","phase-1-safety-of-intrathecal-riluzole-in-patients-with-amyotrophic-lateral-sclerosis-100600113","NCT07093268","Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis","A Phase 1 Study to Determine the Safety and Tolerability of Continuous Intrathecal Riluzole in Patients With Progressive Ambulatory Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* Men and women aged 18 years or older.\n* Participants are ambulatory with or without an assistive device.\n* Sporadic or familial ALS diagnosis with possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.\n* Slow vital capacity (SVC) measure ≥70% of predicted for gender, height, and age.\n* Medically able to undergo implantation of the SynchroMed II Infusion Pump according to the judgment of the investigator, or the presence of a previously implanted IT pump (not to be used for concurrent IT infusion of another IT agent).\n* Capable of reading and providing informed consent and following study procedures.\n* Geographic accessibility to the study center and the ability to travel to the clinic for study visits by ground transportation.\n* Women must not be able to become pregnant (eg, post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and 3 months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device in place for ≥3 months, barrier method in conjunction with spermicide, or another adequate method.\n* Taking and tolerating oral riluzole 50 mg twice a day for at least 30 days prior screening and willingness to continue oral riluzole throughout duration of the study.\n* Patients may take other drugs approved for treatment of ALS at the dose prescribed by their neurologist.\n\nExclusion Criteria:\n\n* Participants with bulbar-onset ALS\n* Participants at risk of increased bleeding or uncontrolled bleeding during the SynchroMed II Infusion Pump implantation or following explant. This includes but is not limited to:\n\n  1. Anatomical factors at or near the site of implantation;\n  2. Underlying disorders of the coagulation cascade or platelet function (eg, hemophilia, Von Willebrand's disease, liver disease);\n  3. Administration of antiplatelet or anticoagulant medication within 7 days before or after pump implantation (eg, aspirin, clopidogrel bisulfate, rivaroxaban, nonsteroidal anti-inflammatory agents \\[NSAIDs\\]), or\n  4. Use of nutritional supplements (eg, St John's Wort) within 7 days before or after pump implantation.\n* Presence of infection including but not limited to: meningitis, ventriculitis, skin infection, bacteremia, or septicemia.\n* Testing positive for HIV (anti-HIV antibody), HBV (HBV surface antigen) or HCV (anti-HCV antibody; HCV RNA if anti-HCV antibody is positive) at screening.\n* Inability to have the infusion pump implanted ≤ 2.5 cm below the skin surface.\n* Body weight and size unable to accept the infusion pump bulk and weight.\n* Spinal anomalies which would complicate the implantation and fixation of the catheter for IP delivery.\n* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) value \\> 2.0 times the upper normal.\n* A life expectancy of less than 6 months, based on the judgment of the investigator.\n* Presence of tracheostomy.\n* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair the ability of the participant to provide informed consent, per investigator judgment.\n* History of active substance abuse within the prior year.\n* At risk for committing suicide per investigator judgment.\n* Clinically significant history of unstable or severe cardiac, oncologic, hepatic, or renal disease, or other medically significant illness.\n* Pregnant women or women currently breastfeeding.\n* Exposure to any investigational drug, device, or biologic within 30 days of screening.",{"count":57,"type":22},[439],"PHASE1","The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.",[203,29],[236,363,443],"Neuromuscular Diseases","NOT_YET_RECRUITING","2025-07-22",{"date":447,"type":38},"2025-07-30",{"date":449,"type":22},"2025-08-15",{"date":451,"type":22},"2027-01-15",{"name":453,"class":82},"Brain Trust Bio",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":46},"100592374","uae-prime-a-feasibility-study-of-a-precise-robotically-implanted-brain-computer-interface-for-the-control-of-external-devices-100592374","NCT06992596","UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","UAE-PRIME","Inclusion Criteria:\n\n* (a) A diagnosis of a spinal cord injury (\\>12 months), stroke (\\>12 months), or other neurological condition causing the participant to experience bilateral upper limb motor impairment, with no expectation of recovery.\n\nOR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation, in the view of the participant's treating neurologist, that the disease will progress such that the participant will meet criteria 1a within 1 year of recruitment.\n\n* Life expectancy ≥ 12 months.\n* Ability to communicate verbally or with the use of a computer or communication aid, and working proficiency in English.\n* Presence of a stable caregiver\n\nExclusion Criteria:\n\n* Moderate to high risk for serious perioperative adverse events\n* Morbid obesity (Body Mass Index \\> 40)\n* History of poorly controlled seizures or epilepsy\n* History of poorly controlled diabetes\n* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions\n* Acquired or hereditary immunosuppression\n* Smoking tobacco or use of other tobacco products \\> once per month within the last year.\n* Psychiatric or psychological disorder\n* Pre-existing damage to the cortical region of interest (as determined by MRI)\n* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure",{"count":57,"type":22},[25],"The UAE-PRIME Study is a feasibility study designed to assess the initial clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.\n\nThe N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.",[396,397,398,399,400,401,402,29,403],[405,406,407,408,409,410,411,67,131,412,413,414,415,416,417,418,419,420],"2025-06-03",{"date":468,"type":38},"2025-06-05",{"date":470,"type":38},"2025-05-09",{"date":472,"type":22},"2027-11",{"name":429,"class":82},{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":494},"100540573","biomarker-driven-phenotypic-dissection-of-amyotrophic-lateral-sclerosis-100540573","NCT06318598","Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis","Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica\u002FBiomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis","DRIVEALS","Inclusion Criteria:\n\n* diagnosis of ALS or other motor neuron disease\n* residence near the study centers\n\nExclusion Criteria:\n\n* refusal to participate to the study\n* unable\u002Funwilling to perform follow-up visits",{"count":231,"type":22},"The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:\n\n* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?\n* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?\n\nParticipants will undergo:\n\n* neurological evaluation\n* neurophysiological evaluation\n* neuropsychological evaluation\n* whole exome sequencing\n* biomarker measurement in CSF and plasma",[203,29],"2025-05-05",{"date":487,"type":38},"2025-05-07",{"date":489,"type":38},"2023-04-11",{"date":491,"type":22},"2026-04-10",{"name":493,"class":145},"Istituto Auxologico Italiano",3,{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":46},"100540572","creation-of-a-clinical-database-for-the-study-of-phenotypic-variability-in-motor-neuron-diseases-100540572","NCT06318585","Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases","Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone","ALS-PHENO","Inclusion Criteria:\n\n* diagnosis of ALS or other motor neuron disease\n\nExclusion Criteria:\n\n* refusal to participate to the study",{"count":231,"type":22},"Study Description: Characterization of Motor Neuron Disease Phenotypes\n\nThe goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:\n\n* What are the specific clinical phenotypes associated with MND?\n* How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?\n\nParticipants will undergo:\n\n* Clinical evaluation using validated scales\n* Neurophysiological and neuroradiological instrumental assessment\n* Neuropsychological evaluation\n* Collection of biological materials for genetic screening and biomarker assessment, if necessary.",[203,29],{"date":487,"type":38},{"date":508,"type":38},"2023-04-03",{"date":510,"type":22},"2026-12-31",{"name":493,"class":145},{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":522,"conditions":523,"keywords":526,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":542},"100416712","systematic-assessment-of-laryngopharyngeal-function-in-patients-with-neurodegenerative-diseases-100416712","NCT04706234","Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases","Prospective Observational Study for the Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases","FEEMSA","Inclusion Criteria:\n\n* diagnosis of probable or possible multiple system atrophy according to current consensus criteria (Gilman et al. 2008) or\n* diagnosis of probable or possible PSP according to the the Movement Disorders Society (MDS) diagnostic criteria (Höglinger et al. 2017) or\n* diagnosis of Parkinson's disease according to the MDS diagnostic criteria (Postuma et al 2015)\n* Hoehn and Yahr Stage within the range of I-V or\n* diagnosis of motor neurone disease or\n* diagnosis of a neurodegenerative disease other than specified above\n\nAND underwent laryngopharyngeal assessment according to the systematic task protocol during FEES (Warnecke et al. 2019).\n\nExclusion Criteria:\n\n\\- Patients who do not sign the consent form",{"count":521,"type":22},350,"This is a non-interventional observational study designed to systematically record the results of routine laryngeal examinations and specific characteristics of dysphagia in patients with neurodegenerative disorders. The results of a fiberoptic \u002F flexible endoscopic evaluation of swallowing (FEES) while performing a structured task protocol will be recorded. If available, laryngeal electromyography (EMG) results will also be recorded. In addition to the examination results, demographic and disease-specific data are collected, and two questionnaires, the Swallowing Disturbance Questionnaire for Parkinson's Disease (SDQ-PD) and the swallowing specific Quality Of Life Questionnaire (SWALQOL), are administered.",[524,341,525,29,236],"Multiple System Atrophy","Progressive Supranuclear Palsy",[524,525,527,29,236,528,529,530,531,532],"Parkinson's disease","Dysphagia","FEES","Laryngeal EMG","Irregular Arytenoid Cartilages Movements","Clinical Biomarker","2025-04-07",{"date":535,"type":38},"2025-04-09",{"date":537,"type":38},"2017-09-01",{"date":539,"type":22},"2028-07-31",{"name":541,"class":145},"Kliniken Beelitz GmbH",16,{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":16,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":46},"100584175","als-research-collaborative-100584175","NCT06885918","ALS Research Collaborative","ALS Translational Research Program","ARC","Inclusion Criteria:\n\n* 18 years of age or older\n* Can communicate in written English\n* Has a diagnosis of ALS\u002FMND or is a known carrier of an ALS associated mutation\n\nExclusion Criteria:\n\n* Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.",{"count":552,"type":22},2000,"The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute.",[203,94,555,29,63],"ALS With Frontotemporal Dementia (ALS\u002FFTD)",[549,547,557,558],"ALS TDI","ALS Therapy Develeopment Institute","2025-03-13",{"date":561,"type":38},"2025-03-20",{"date":563,"type":38},"2014-09-12",{"date":565,"type":22},"2035-01-31",{"name":567,"class":145},"ALS Therapy Development Institute",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":17,"minAge":575,"maxAge":113,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100349236","awareness-detection-and-communication-in-disorders-of-consciousness-100349236","NCT03827187","Awareness Detection and Communication in Disorders of Consciousness","EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability","Study 1 - Initial assessment\u002Fscreening\n\nInclusion Criteria:\n\n* Disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in low awareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome \u002F completed locked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems that would preclude them from participating may be assessed but considered as a separate cohort to those with low awareness states.\n* acute, post-acute patients where appropriate\n\nExclusion Criteria:\n\n* Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolled epilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable for the trials by clinical teams.\n* Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning\n* Where English is not the individual's first language\n* Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.\n\nStudy 2 - BCI training\n\nInclusion Criteria:\n\n\\- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and\u002For those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.\n\nExclusion Criteria:\n\n\\- Participants who have shown no active brain responses in study 1 where the difference between baseline","10 Years",{"count":200,"type":22},[25],"STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are \"awake\" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.",[580,65,29,123,581],"Disorder of Consciousness","Physical Disability","2024-12-09",{"date":584,"type":38},"2024-12-13",{"date":586,"type":38},"2022-02-08",{"date":588,"type":22},"2026-08",{"name":590,"class":145},"University of Ulster",18,{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":599,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":603,"conditions":604,"keywords":607,"overallStatus":444,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":4},"100540343","phase-2-mrg-001-in-patients-with-amyotrophic-lateral-sclerosis-100540343","NCT06315608","MRG-001 in Patients With Amyotrophic Lateral Sclerosis","An Open-Label, Proof of Concept Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* Able to provide written informed consent (either from patient or patient's legally acceptable representative and complying with study procedures, in the PI's opinion.\n* Male or female patients between 18-75 years.\n* Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.\n* Time since onset of weakness due to ALS ≤ 48 months at the time of the Screening Visit\n* Vital Capacity ≥ 50% of predicted capacity for age, height, and sex at the time of the Screening Visit measured by Slow Vital Capacity (SVC), or Forced Vital Capacity (FVC).\n* Patients must either not take Riluzole or be on a stable dose of Riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study.\n* Participants must either not take Edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study.\n* Participants must either not take Relyvrio (AMX0035) or be on a stable dose of Relyvrio for ≥ 30 days prior to the Master Protocol Screening Visit. Relyvrio-naïve participants are permitted in the study.\n* Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrhoeic for at least 12 months) must utilize appropriate birth control throughout the study duration.\n* Male patients must agree to use a medically acceptable method of contraception \u002Fbirth control throughout the study duration.\n\nExclusion Criteria:\n\n* Subjects who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:\n* Participation in another interventional clinical trial (drug or device) within 30 days of Screening and at any time during the study.\n* Significant pre-existing organ dysfunction prior to randomization:\n* Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.\n* Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg.\n* Renal: End-stage renal disease requiring renal replacement therapy or creatinine clearance \\\u003C50 mL\u002Fmin.\n* Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL.\n* Neurological: Stage ≥3 hepatic encephalopathy by West Haven criteria.\n* History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n* Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.\n* Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational) including tofersen (Qalsody).\n* History of splenectomy or splenomegaly (spleen weighing \\>750 g).\n* Co-infection with human immunodeficiency virus (HIV).\n* History of organ or bone marrow transplantation, other than a corneal transplant.\n\nor recent (within 3 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1\u002F2 inhibitors, interferons, interleukins or (prednisone or related corticosteroids are allowed).\n\n* Hypersensitivity to either of the components of MRG-001.\n* If female, known pregnancy, or has a positive serum pregnancy test, or lactating\u002Fbreastfeeding.\n* Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.","75 Years",{"count":57,"type":22},[602],"PHASE2","The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months.",[203,605,29,606],"Lou Gehrig Disease","Motor Neuron Atrophy",[608,609,610,611],"MRG-001","Stem Cells","Regulatory T-cells","Fixed-Dose Combination","2024-08-22",{"date":614,"type":38},"2024-08-23",{"date":616,"type":22},"2025-07-01",{"date":618,"type":22},"2026-03-01",{"name":620,"class":82},"MedRegen LLC",{"id":622,"slug":623,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":16,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":167},"100559632","emotion-processing-among-patients-with-als-100559632","NCT06566651","Emotion Processing Among Patients With ALS","Emotion and Interoception Processing in ALS","Inclusion Criteria:\n\n* ALS patients, ambulant and hospitalized\n\n  * Able to give informed consent\n  * Diagnosed with ALS or probable ALS according to the existing revision of the El Escorial Criteria 21,22.\n* Patients with a peripheral neuromuscular disease, ambulant and hospitalized\n\n  * Able to give informed consent\n  * Diagnosed with a peripheral neuromuscular disease, that does not affect CNS, including but not limited to Myasthenia Gravis and polyneuropathy\n* Healthy controls\n\n  * Able to give informed consent\n  * Age and gender matched to ALS patients\n\nExclusion Criteria:\n\n* All Participants\n\n  * Other severe medical, neurological, or psychiatric disorders\n  * Visual impairment to an extent that interferes with the ability to perform of the test\n  * Severe motor or cognitive deficits, to the extent that the test-task cannot be performed\n  * Alcohol or drug abuse to an extent the interferes with task performance\n* Patients with a peripheral neuromuscular disease\n\n  ● Familial predisposition to ALS\n* Healthy controls\n\n  * Familial predisposition to ALS (first degree relatives)\n  * Medical treatment that affects the central nervous system (e.g., antidepressants)",{"count":629,"type":22},180,"The goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. The main questions it aims to answer are:\n\n* How people with ALS judge happy and angry faces and what their \"insight\" into these judgements are like\n* How their autonomic responses differ from the other two test group Participants will asked to judge if a face presents a happy emotion or angry emotion.\n\nResearchers will compare the ALS group responses with neuromuscular diseases group and healthy control group responses to see if the ALS group judge more happy faces than angry.",[203,443,67,29,62],[203,443,633,634,635,636,637,638,639,67,640,70],"Emotion Perception","Emotion Processing","Emotion Recognition","Autonomic Responses","Respiratory Responses","Heart rate","Emotion Discrimination Task","Motorneuron disease","2024-08-20",{"date":612,"type":38},{"date":644,"type":38},"2023-12-15",{"date":646,"type":22},"2026-06-30",{"name":648,"class":145},"University of Aarhus",{"id":650,"slug":651,"hasResults":11,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":16,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":444,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":4},"100557727","gait-patterns-in-dual-task-conditions-in-patients-with-amyotrophic-lateral-sclerosis-100557727","NCT06541873","Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis","DuALS - A Cross-sectional Observational Study of Gait Patterns in Dual-task Conditions in Patients With Amyotrophic Lateral Sclerosis","Patient inclusion criteria:\n\n* Age ≥ 18 years;\n* Clinical diagnosis of ALS or other MND phenotype;\n* Able to walk unassisted for at least 1 minute consecutively;\n* Oral and written informed consent to study participation.\n\nHealthy control inclusion criteria:\n\n1. Age ≥ 18 years;\n2. Age and sex distribution similar to patients (age range: mean age of patients years ± 15 years);\n3. Able to walk unassisted for at least 1 minute consecutively;\n4. Oral and written informed consent to study participation.\n\nExclusion Criteria\n\nAn individual (either patient or healthy control) who meets any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of dementia;\n2. Medical conditions or substance abuse that could interfere with cognition;\n3. Any (other) major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability.",{"count":657,"type":22},60,"The investigators hypothesize a relevant impact of cognitive status over gait performance in patients with amyotrophic lateral sclerosis (ALS), contributing to poor mobility and representing a relevant risk for falls. The present observational, cross-sectional study on ambulatory patients with ALS will evaluate gait performance using different sets of dual-task conditions to demonstrate the importance of cognitive aspects in rehabilitation programs for these patients. The dual-task conditions to be assessed during gait performance will include: counting backwards by 3 (executive simple task); counting backwards by 7 (executive complex task); mnemonic recall of the Rey's Auditory Verbal Learning Test (RAVLT). Patients' performance will be compared with a group of healthy controls with similar age and sex distribution in order to highlight the specific effects of the disease.",[203,29],"2024-08-02",{"date":662,"type":38},"2024-08-07",{"date":664,"type":22},"2024-09",{"date":666,"type":22},"2027-08-31",{"name":668,"class":145},"IRCCS San Raffaele",{"id":670,"slug":671,"hasResults":11,"nctId":672,"briefTitle":673,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":16,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":677,"conditions":678,"keywords":680,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":686,"lastUpdatePostDateStruct":687,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":692,"locationsCount":694},"100275728","amyotrophic-lateral-sclerosis-and-the-innate-immune-system-100275728","NCT02869048","Amyotrophic Lateral Sclerosis and the Innate Immune System","Inclusion Criteria:\n\n* For ALS group:Diagnosed with the diagnose category \"certain ALS\" or \"likely ALS according to the El Escorial rev. diagnose criteria\n* For Neurological control group: Referred to neurological department to be examined for acute or chronic headache or referred to get a lumbar perfusion test performed.\n\nExclusion Criteria:\n\n* For all groups (Clinical study 2-3): permanent contraindication for having a lumbar puncture performed\n* For Neurological control group: Known with chronic inflammatory disease or autoimmune disease.\n* For healthy control group (clinical study 1): Known with any disease\n* For healthy control group (clinical study 1): Taking daily medication\n* For Neurologically healthy control group (Clinical study 2): Known with neurological disease\n* For Neurologically healthy control group (Clinical study 2): Known with chronic inflammatory disease or autoimmune disease.",{"count":676,"type":22},375,"Amyotrophic Lateral Sclerosis (ALS) is an aggressive, deadly disease. ALS leads to destruction of the neural pathways which control the conscious movements of the muscles. This destruction leads to muscular dystrophy with increasing difficulties in moving, breathing, swallowing, and speaking. In the last phase of an ALS patient's life it is necessary with respiratory therapy in order to breathe. In average an ALS patient lives 3 years from the time he or she gets the diagnose.\n\nThe cause of the disease is still unknown and there is currently no treatment which can stop the progression of the disease. Former clinical studies have indicated that the innate immune system and in particular the complement system plays a significant role in the progression of ALS. The complement system, which is activated in cascades, is part of the innate system but participates in the innate as well as the acquired immune system. Former clinical trials have been characterized by limited knowledge about both the complement system as well as to how it is measured.\n\nToday it is possible to measure directly on the different components of the complement system and to understand its contribution to the overall immune response. It is also possible today to detect defects of the complement system. All these progressions are the foundation for this project which is carried out in close cooperation with one of the world's leading researchers in the complement system, professor Peter Garred from Rigshospitalet.\n\nThe aim is to make a national research project about ALS in order to investigate the role of the innate immune system, and especially the complement system, in patients with ALS.\n\nIn the long term the hope is, that this will lead the way to a targeted and effective medical treatment to the people affected by this grave disease.",[203,679,29],"Neurodegenerative Disease",[681,682,683,684,412,240,685],"Biological Specimen Banks","Innate Immunity","Clinical Study","Complement system proteins","Motor neuron disease","2017-10-04",{"date":688,"type":38},"2017-10-06",{"date":690,"type":4},"2016-06",{"date":348,"type":22},{"name":693,"class":145},"Rigshospitalet, Denmark",8]