[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"motor-neuron-disease-amyotrophic-lateral-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:motor-neuron-disease-amyotrophic-lateral-sclerosis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,82,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":14,"conditions":25,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100633993","functional-outcomes-and-control-using-synchron-bci---australia-100633993",false,"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.","ALL","21 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA",[26,27,28,29,30,31,32],"Neurologic Disorder","Neurologic Diseases","MND (Motor Neurone DIsease)","Motor Neuron Disease","Motor Neuron Disease, Amyotrophic Lateral Sclerosis","Paralysis Arm","Paralysis",[34,35,36,37,38,39],"ALS","BCI","Brain Computer Interface","MND","Upper Limb Paralysis","Motor Neurone Disease","RECRUITING","2026-06-05",{"date":43,"type":44},"2026-06-09","ACTUAL",{"date":46,"type":44},"2026-05-22",{"date":48,"type":21},"2027-12",{"name":50,"class":51},"Synchron, Inc.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":37,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":52},"100607348","investigating-the-impact-of-electrical-stimulation-on-facial-pain-jaw-movement-and-oral-health-in-people-with-motor-neuron-disease-100607348","NCT07187388","Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.","The Impact of Transcutaneous Electrical Stimulation on Facial Pain, Jaw Mobility, and Oral Health in Individuals With Motor Neuron Disease.","Inclusion Criteria:\n\n* Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited) OR diagnosis of definite PLS by the treating neurologist and based on the consensus diagnostic criteria for PLS\n* Subjective report of jaw pain, indicated by a NRS score of \\> or = 3\u002F10.\n\nExclusion Criteria:\n\n* history of head or neck cancer\n* history of CVA\n* history of past facial surgery with hardware placement\n* history of pacemaker\n* diagnosis of significant cognitive impairment by the treating physician\n* history of seizures or diagnosis of epilepsy\n* open wound at the area of electrode placement\n* complete loss of sensation at the area of electrode placement","18 Years",{"count":20,"type":21},[24],"The goal of this clinical trial is to evaluate the impact of non-invasive electrical stimulation, when placed on the facial muscles can reduce facial pain and improve jaw mobility, and chewing in individuals with Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS). The secondary goal is to evaluate the impact of non-invasive electrical stimulation on patient reported difficulty performing oral hygiene tasks in individuals with ALS and PLS. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention assessments, a single 30-minute treatment of electrical stimulation followed by post-intervention assessments.\n\nThe assessments will include a self-rating of jaw and facial pain, a range of motion test where participants will be asked to open their jaw as wide and as far to the side as possible, and a chewing efficiency test using a saltine cracker. Twenty-four hours later, participants will receive a follow-up phone call to self-rate their facial pain and report any difficulty performing oral hygiene tasks.\n\nThe treatment consists of a single 30-minute electrical stimulation session. Electrode pads will be placed on the participant's facial region, specifically over the masseter muscle belly and the TMJ area, while the participant is seated comfortably. The pads will be connected to an FDA-approved electrical stimulator, and the current will be adjusted to the participant's comfort level. Once set, the participant will remain seated for 30 minutes. At the end of the session, the stimulator will be turned off and the electrode pads removed.",[65,66,30],"Amyotrophic Lateral Sclerosis (ALS)","Primary Lateral Sclerosis (PLS)",[68,69,34,70,29,37,71,72],"Amyotrophic Lateral Sclerosis","Primary Lateral Sclerosis","PLS","Facial Pain","jaw pain",{"date":74,"type":44},"2026-05-27",{"date":76,"type":44},"2026-04-02",{"date":78,"type":21},"2026-08-13",{"name":80,"class":81},"Nova Southeastern University","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100385758","phase-2-motor-neurone-disease---systematic-multi-arm-adaptive-randomised-trial-100385758","NCT04302870","Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial","MND-SMART","Participants will be considered eligible for randomisation if they fulfil all the core inclusion criteria and none of the exclusion criteria as defined below. In addition, investigators must simultaneously check and ensure participants do not meet any of the drug specific exclusion criteria. If exclusion criteria are met for an arm, participants can still be considered for other arms and randomised accordingly to eligible arms.\n\nCore inclusion criteria:\n\n* Confirmed diagnosis of MND. This includes the following subtypes: ALS by El Escorial Criteria (possible, probable, and definite) or Gold Coast Criteria, Primary Lateral Sclerosis, and Progressive Muscular Atrophy\n* Over 18\n* Women of childbearing potential according to CTFG guidelines must have a negative pregnancy test within 7 days prior to, or at, the baseline visit\n* Women of childbearing potential and fertile men must be using an appropriate method of contraception to avoid any unlikely teratogenic effects of the selected drugs from time of consent, to 4 weeks after treatment inclusive\n* Willing and able to comply with the trial protocol and ability to understand and complete questionnaires\n* Written informed consent (in the case of limb dysfunction verbal consent can be given in the presence of a witness who can sign)\n\nCore Exclusion Criteria:\n\n* Patients diagnosed with Frontotemporal Dementia (FTD-MND) or any other significant psychiatric disorder that prevents informed consent being given.\n* Alcoholism (current self-reported - at the investigator's discretion)\n* Active suicide ideation assessed using the Columbia-Suicide Severity Rating Scale\n* On concurrent investigational devices and medication (including biological therapy)\n* Pregnancy or breast-feeding females\n* If ALT, ALP, bilirubin or GGT \\>3 times the upper limit of normal.\n* If creatinine clearance (creatinine clearance or eGFR) \\\u003C35 ml\u002Fmin.\n* If TSH \\\u003C0.2mU\u002Fl (if possible to test free T4, then Serum free T4 \\>25pmol\u002Fl)\n* If corrected QT interval on 12 lead ECG \\>500 ms\n* Patient's diagnosed with ventricular arrhythmias, significant heart block (at the investigator's discretion)) or in the immediate recovery period after myocardial infarction (\\\u003C 6 weeks).\n* Patients who the PI considers will not be able to comply with the study protocol.\n\nAmantadine Exclusion Criteria:\n\n* Patients in the manic phase of bipolar disorder.\n* Patients with history of proven peptic ulcer confirmed on endoscopy\n* Patients with active epilepsy\n* Already taking the IMP in this comparison\n* Known hypersensitivity, including hereditary fructose intolerance, or adverse reaction to the active substances and their excipients (as per SPCs for this comparison) or any past medical history contraindicating use of the IMP in this comparison\n\nTacrolimus Exclusion Criteria:\n\n* Poorly controlled hypertension (Systolic BP\\>180 mmHg or Diastolic BP\\>100mmHg)\n* Poorly controlled diabetes (HbA1c\\>6.4% or 48mmol\u002Fmol)\n* Hypertrophic cardiomyopathy or history of QT prolongation (including family history), congestive heart failure, bradyarrhythmias, and electrolyte abnormalities\n* History of bleeding disorders or significant haematological or immune diseases including, congenital or acquired immune deficiency, anaemia (Hb\\\u003C130g\u002FL for males and Hb\\\u003C120 g\u002FL in females) and thrombocytopenia (platelet count \\\u003C150 × 109\u002FL), use of other biological agents and immunosuppressant medications including oral\u002FIV steroids\n* Active or chronic infection (at PI discretion)\n* History of Hepatitis B or C\n* History of lymphoma and active malignancy\n* Risk of dehydration due to reduced oral intake and lack of parenteral route\n* Patient's contraindicated to tacrolimus according to SPC section 4.3\n* Use of concomitant medications that interacts with tacrolimus according to the SPC, including but not limited to strong CYP3A4 inhibitors (i.e. azoles, protease inhibitors) or CYP3A4 inducers (rifampicin, phenytoin, carbamazepine), barbiturates, macrolides, digoxin, statins, PPI inhibitors, ergotamine, tricyclic antidepressants, herbal supplements (St. John's wort, extracts of Schisandra sphenanthera)\n* Inability to swallow capsules\n* Already taking the IMP in this comparison\n* Known hypersensitivity, including lactose and gelatin intolerance, or adverse reaction to the active substances and their excipients (as per SPCs for this comparison) or any past medical history contraindicating use of the IMP in this comparison\n* Receipt of a live attenuated vaccine within four weeks prior to receipt of tacrolimus. These include, but are not limited to live influenza vaccine (Fluenz Tetra), Shingles (varicella zoster virus) Zostavax, Varicella (Varilrix, Varilvax), Oral typhoid (Ty21a), and yellow fever vaccines.",{"count":90,"type":21},1150,[92,93],"PHASE2","PHASE3","MND-SMART is investigating whether selected drugs can slow down the progression of motor neuron disease (MND) and improve survival.\n\nThe study is 'multi-arm' meaning more than one treatment will be tested at the same time. The trial started with 3 arms; drug 1 (memantine), drug 2 (trazodone) and placebo (dummy drug). A third drug, amantadine, was added in April 2023. A fourth drug, tacrolimus, was added in March 2025 in Edinburgh and across all sites in April 2025. The first two drugs, memantine and trazodone, were removed from the trial in September 2023 due to lack of benefit. The trial currently has 4 recruiting arms; amantadine, liquid placebo (matched to amantadine), tacrolimus, and tablet placebo (matched to tacrolimus). This allows the evaluation of each drug versus placebo. Participants will be randomly allocated between the treatment arms they are eligible for. Medicines being tested are already approved for use in other conditions.\n\nMND-SMART has an 'adaptive' design. This means medicines being studied can change according to emerging results. Treatments shown to be ineffective can be dropped and new drugs can be added over the duration of the study. This will allow many treatments, over time, to be efficiently and definitively evaluated.\n\nThe medicines being tested have been selected following a rigorous process involving a systematic, unbiased, and comprehensive review of past clinical trials data, as well as information from pre-clinical research (studies in laboratories), for MND and other related neurodegenerative disorders. Drugs have been ranked for inclusion in MND-SMART by a group of independent MND experts according to set criteria. These include consideration of how the drugs work, their safety profiles, and the quality of previous studies.\n\nNew drugs will be selected for investigation in MND-SMART based on continuous review of constantly updated scientific evidence as well as findings from state-of-the-art human stem cell based drug discovery platforms. These can be added by substantial amendment to the protocol.",[30],"2026-03-02",{"date":98,"type":44},"2026-03-04",{"date":100,"type":44},"2020-02-27",{"date":102,"type":21},"2030-12",{"name":104,"class":81},"University of Edinburgh",22,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":52},"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.",true,{"count":116,"type":21},2000,"OBSERVATIONAL","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.",[68,120,121,29,30],"ALS (Amyotrophic Lateral Sclerosis)","ALS With Frontotemporal Dementia (ALS\u002FFTD)",[112,110,123,124],"ALS TDI","ALS Therapy Develeopment Institute","2025-03-13",{"date":127,"type":44},"2025-03-20",{"date":129,"type":44},"2014-09-12",{"date":131,"type":21},"2035-01-31",{"name":133,"class":81},"ALS Therapy Development Institute"]