[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ecole Polytechnique Fédérale de Lausanne\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":219},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,69,93,124,146,178,198],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643146","brain-controlled-spinal-cord-stimulation-in-participants-with-chronic-stroke-for-lower-and-upper-limb-rehabilitation-100643146",false,"NCT07610850","Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation","Stroke-BSI","Inclusion Criteria:\n\n* Must be between 18-70 years old at the time of enrolment.\n* Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment.\n* Must have a score lower than 25 on the Fugl-Meyer upper-limb scale.\n* Must be able to stand with or without assistive device for 30 seconds.\n* Must have a score higher than 22 at the Montreal Cognitive Assessment.\n* Must present right or left hemiplegia.\n* Must have completed primary standard of care rehabilitation.\n* Must provide and sign the study's Informed Consent prior to any study-related procedures.\n* Must be able to understand and interact with the study team in French or English.\n* Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.\n* Must use effective contraception for women of childbearing capacity.\n* Must be able to withhold antiplatelet\u002Fanticoagulation agents perioperatively for the time of the surgeries (if applicable).\n\nExclusion Criteria:\n\n* Must not be pregnant or breast feeding (if applicable).\n* Must not have the intention to become pregnant during the study (if applicable).\n* Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery.\n* Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by the psychologist.\n* Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., major cognitive disorder, renal failure, hepatic dysfunction, epilepsy, etc.).\n* Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support.\n* Must not have any active implanted device, such as a pacemaker or other neurostimulator.\n* Must not have any spinal anatomical abnormalities or incompatibilities with the implanted system precluding surgery.\n* Must not have severe spasticity of the upper limb or lower limb (Modified Ashworth Scale \\> 3).\n* Must not have indication requiring frequent MRIs.\n* Must not participate in another clinical study using drugs or medical devices that might interfere with the outcomes of the study.\n* Must not be the investigator him\u002Fherself, his\u002Fher family members, employees, and other dependent persons.","ALL","18 Years","70 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with cervical and lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of upper and lower limbs in participants with chronic stroke suffering from mobility impairment.\n\nThe goal is to establish a direct bridge between the motor intention of the participant and the spinal cord, which should not only improve or restore voluntary control of arm and leg movement and support immediate mobility, but also promote neurological recovery when combined with neurorehabilitation.",[27,28],"Stroke","Hemiplegia",[30,31,32],"Spinal cord stimulation","Brain computer interface","Brain spine interface","RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2032-10",{"name":43,"class":44},"Ecole Polytechnique Fédérale de Lausanne","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100538805","study-on-preliminary-safety-and-efficacy-of-the-arc-im-therapy-to-alleviate-locomotor-deficits-in-people-with-parkinsons-disease-100538805","NCT06295614","Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease","SPARKL","Inclusion Criteria:\n\n* Typical form of Parkinson's Disease with II-IV Hoehn-Yahr stage with standard therapy,\n* Suffering from debilitating locomotor deficits, including gait impairments of either postural instability and\u002For freezing of gait, despite optimal medical management,\n* 18 years of age or older,\n* Able to understand and interact with the study team in French or English,\n* Must use safe contraception for women of childbearing capacity,\n* Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits.\n* Must provide and sign the study's Informed Consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Atypical forms of Parkinson's Disease (such as Multiple System Atrophy or Progressive Supranuclear Palsy),\n* Secondary causes of gait problems independent of Parkinson's Disease,\n* Inability to follow study procedures,\n* Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator,\n* History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist,\n* Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation),\n* Diseases and conditions that would increase the morbidity and mortality of the implantation surgery,\n* Spinal anatomical abnormalities precluding surgery,\n* History of drug or alcohol abuse in the past 5 years,\n* Life expectancy of less than 12 months,\n* Pregnant or breast feeding,\n* Intention to get pregnant during the course of the study,\n* Indication requiring frequent Magnetic Resonance Imaging (MRI),\n* Experimental treatment taken in the past 5 years,\n* Participation in another interventional study,\n* Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons.",{"count":54,"type":21},6,[24],"The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease.",[58],"Parkinson Disease",[58,60,61],"Spinal Cord Stimulation","Epidural Spinal Stimulation",{"date":63,"type":37},"2026-06-04",{"date":65,"type":37},"2024-02-14",{"date":67,"type":21},"2029-04-01",{"name":43,"class":44},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100490428","brain-controlled-spinal-cord-stimulation-in-participants-with-cervical-spinal-cord-injury-for-upper-limb-rehabilitation-100490428","NCT05665998","Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation","Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation (UP2)","UP2","* Must provide Informed Consent as documented by signature (Appendix Informed Consent Form),\n* Must be at least 18 years old and no older than 75 years old at the time of enrolment,\n* Must be suffering from non-progressive traumatic cervical spinal cord injury,\n* Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,\n* Must have completed primary standard of care rehabilitation,\n* Must be severely impaired in his upper limb function as determined by the investigator,\n* Must have sustained the injury at least 6 months before signing the consent form,\n* Must be able to understand and interact with the study team in French or English,\n* Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments,\n* Must use safe contraception for women of childbearing capacity,\n* Must not be pregnant nor breast feeding,\n* Must not have history of severe autonomic dysreflexia,\n* Must not have brain damage,\n* Must not have history of epilepsy,\n* Must not have spinal stenosis,\n* Must not have gastrointestinal ulcers in the last five years,\n* Must not have any psychological disorder,\n* Must not have the intention to become pregnant during the course of the study,\n* Must not be known or suspected of drug or alcohol abuse,\n* Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study,\n* Must not have previously been injected with stem cells in the spinal cord,\n* Must not be the investigator himself, his\u002Fher family members, employees or other dependent persons,\n* Must not have any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator,\n* Must not have any hematological disorders with increased risk for surgical intervention,\n* Must not require ventilator support,\n* Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc),\n* Must not be subject to spasms that limit the ability of the subject to participate in the study training as determined by the investigator,\n* Must not display spinal stenosis or post traumatic damage at location of implantation,\n* Must not require the use of an intrathecal baclofen pump,\n* Must not be implanted with a device such as pacemakers or defibrillators,\n* Must not have any indication that would require an MRI,\n* Must not suffer from congenital nor acquired upper limb abnormalities (affection of joints or bones).","75 Years",{"count":20,"type":21},[24],"Cervical spinal cord stimulation can elicit arm and hand movements through recruitment of proprioceptive neurons in the dorsal roots. In participants with cervical spinal cord injury, the spare roots bellow the lesion can be used to reactivate motor function. Decoding of motor intentions can be achieved through implantable electrocorticography (ECoG) devices.\n\nIn this study, the investigators will use an investigational system using ECoG signal recording over the motor cortex to drive muscle specific electrical epidural spinal cord stimulation (EES). The investigators will assess the safety and preliminary efficacy of this system in 3 participants.",[82,83],"Cervical Spinal Cord Injury","Tetraplegia",[30,31,32],"2026-04-20",{"date":87,"type":37},"2026-04-23",{"date":89,"type":37},"2023-05-22",{"date":91,"type":21},"2026-12-31",{"name":43,"class":44},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":112,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100611001","arc-im-therapy-to-support-and-promote-recovery-of-ambulatory-functions-in-people-with-subacute-and-chronic-spinal-cord-injury-100611001","NCT07234903","ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury","EIGER","Inclusion Criteria:\n\n1. Must be at least 18 years old and no older than 65 years old at the time of enrollment.\n2. Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).\n3. Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI.\n4. Must have sustained their injury either less than 6 weeks prior to baseline (Group \"Subacute SCI\"), or more than 1 year prior to enrollment (Group \"Chronic SCI\").\n5. Must be suffering from a SCI due to trauma.\n6. Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists.\n7. Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration).\n8. Must be able to understand and interact with the study team in German, French or English.\n9. Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.\n10. Must provide Informed Consent as documented by signature prior to any study-related procedures.\n11. Must have an acceptable or highly effective method of contraception for women of childbearing capacity.\n\nExclusion Criteria:\n\n1. Must not be pregnant nor breastfeeding.\n2. Must not have brain damage.\n3. Must not have a history of epilepsy\n4. Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study.\n5. Must not have previously been injected with stem cells in the spinal cord.\n6. Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery.\n7. Must not require ventilator support.\n8. Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).\n9. Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.).\n10. Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation).\n11. Must not require the use of an intrathecal baclofen pump.\n12. Must not have any active implanted devices.\n13. Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).\n14. Must not be the investigator him\u002Fherself, his\u002Fher family members, employees or other dependent persons.","65 Years",{"count":102,"type":21},12,[24],"The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.",[106,107,108,109,110,111],"Spinal Cord Injury","SCI","SCI - Spinal Cord Injury","Subacute Spinal Cord Injury","Chronic Spinal Cord Injury","Spinal Cord Injury (SCI)",[107,106,113,60,114],"Epidural Electrical Stimulation","ARC-IM Therapy","2026-04-16",{"date":117,"type":37},"2026-04-21",{"date":119,"type":21},"2026-04",{"date":121,"type":21},"2032-04",{"name":43,"class":44},2,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":45},"100511661","study-on-preliminary-safety-and-efficacy-of-the-arc-therapy-using-the-arc-im-lumbar-system-to-support-mobility-in-people-with-chronic-spinal-cord-injury-boxswitch-100511661","NCT05942339","Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch)","Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury","BoxSwitch","Inclusion Criteria:\n\n1. Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.\n2. Age 18-65\n3. SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \\& D\n4. SCI ≥ 12months\n5. SCI lesion level T10 and above with preservation of conus function\n6. SCI due to trauma\n7. Stable medical, physical and psychological condition as considered by the investigators\n8. Able to understand and interact with the study team in French or English\n9. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments\n10. Must provide and sign the Informed Consent prior to any study-related procedures\n\nExclusion Criteria:\n\n1. Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery\n2. History of myocardial infarction or cerebrovascular event within the past 6 months\n3. Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)\n4. Any active implanted cardiac device such as pacemaker or defibrillator\n5. Any indication that would require diathermy\n6. Any indication that would require MRI\n7. Any anatomical limitations in the implantation area as judged by the investigators\n8. Other conditions that would make the subject unable to participate in testing in the judgement of the investigators\n9. Clinically significant mental illness in the judgement of the investigators\n10. Presence of indwelling baclofen or insulin pump\n11. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)\n12. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant\n13. Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons\n14. Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding",{"count":5,"type":21},[24],"The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at supporting mobility in participants who have previously received a spinal array and an implantable pulse generator (IPG) either through the STIMO protocol (NCT02936453) or similar studies conducted abroad. They will be proposed to exchange their currently implanted system with components of the newly developed ARC-IM Lumbar system. The goal is to improve more effective lower-limb motor activities, while also simplifying the personal at-home use of the system. In addition, this study aims to evaluate the potential effect of ARC Therapy on muscle tone, bladder, bowel and sexual functions, and quality of life of the participants.\n\nPreliminary safety and efficacy will be assessed in both the short term and throughout the duration of the study (from the surgery to 36 months after the implantation of the ARC-IM Lumbar system).",[136],"Spinal Cord Injuries",[107,106,61],"2025-12-04",{"date":140,"type":37},"2025-12-11",{"date":142,"type":37},"2023-08-30",{"date":144,"type":21},"2027-08-30",{"name":43,"class":44},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":45},"100586803","epidural-electrical-stimulation-to-support-hemodynamic-management-in-individuals-with-parkinsons-disease-100586803","NCT06920134","Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease","Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease","PD-HemON","Inclusion Criteria:\n\n1. \\> 18 years old\n2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)\n3. Confirmed orthostatic hypotension with a test for verticalization\n4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians\n5. Must provide and sign the Informed Consent before any study-related procedures\n6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;\n7. Able to understand and interact with the study team in French or English\n8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments\n\nExclusion Criteria:\n\n1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery\n2. The inability to withhold antiplatelet\u002Fanticoagulation agents perioperatively\n3. History of myocardial infarction or cerebrovascular events within the past 6 months\n4. Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator\n5. History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist\n6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)\n7. Inability to follow study procedures.\n8. Spinal anatomical abnormalities precluding surgery\n9. Presence of any indications requiring frequent MRIs.\n10. Current pregnancy or current breastfeeding\n11. Lack of effective or acceptable contraception for women of childbearing capacity\n12. Intention to become pregnant during the study\n13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator\n14. Participation in another interventional study that might confound study endpoint evaluations\n15. Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons","90 Years",{"count":156,"type":21},5,[24],"The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.",[160,161,162,163,164],"Hypotension Symptomatic","Parkinson's Disease","Orthostatic Hypotension, Dysautonomic","Multiple System Atrophy (MSA) With Orthostatic Hypotension","Multiple System Atrophy - Parkinsonian Subtype (MSA-P)",[166,167,168,169],"orthostatic hypotension","parkinson&#39;s disease","autonomic failure","hypotension","2025-11-14",{"date":172,"type":37},"2025-11-18",{"date":174,"type":37},"2025-07-03",{"date":176,"type":21},"2031-05-01",{"name":43,"class":44},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":45},"100581099","study-on-preliminary-safety-and-efficacy-of-epidural-electrical-stimulation-to-manage-lower-urinary-tract-dysfunction-after-spinal-cord-injury-100581099","NCT06845904","Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury","ReeVoid","Inclusion Criteria:\n\n* Age 18 or older;\n* Must provide and sign the Informed Consent Form prior to any study-related procedures;\n* Spinal cord injury lesion level above T11 (inclusive);\n* SCI graded as AIS- B, C or D;\n* SCI ≥ 6 months;\n* Confirmed lower urinary tract dysfunction during urodynamic assessment (NDO, DSD);\n* Intolerant, refractory or inefficient to conservative treatment options such as medications and behavioural management;\n* Using intermittent self-catheterization;\n* Stable medical, physical and psychological condition as considered by the investigators;\n* Able to understand and interact with the study team in French or English;\n* Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments;\n\nExclusion Criteria:\n\n* Botulinum toxin vesical injections in the previous 6 months;\n* Presence of non-pharmacological treatments for lower urinary tract dysfunction (e.g. sacral nerve stimulation);\n* Does have or needs a suprapubic catheter or bladder indwelling catheter;\n* Presence of upper urinary tract dilatation or bladder or renal stones;\n* Presence of urethral stricture or significant benign prostate hyperplasia;\n* Presence of significant pressure ulcers;\n* Previous lower urinary tract surgery;\n* Presence of Autonomic Dysreflexia during urodynamic test;\n* Recurrent and symptomatic urinary tract infection (more than 3 per year);\n* Presence of intrathecal baclofen pump;\n* Diseases and conditions that would increase the morbidity and mortality of spinal surgery;\n* Other clinically significant concomitant disease states (e.g., syringomyelia, bladder cancer, renal failure, hepatic dysfunction, cardiovascular disease, etc.);\n* The inability to withhold antiplatelet\u002Fanticoagulation agents perioperatively;\n* Presence of pacemakers for cardiac conditions;\n* Other conditions that would make the subject unable to participate in testing in the judgement of the investigators;\n* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding;\n* Lack of acceptable or highly effective method of contraception for women of childbearing capacity;\n* Intention to become pregnant during the course of the study;\n* Inability to follow the procedures of the study, e.g. due to language problems, mental illness, psychological disorders, or dementia of the participant;\n* Participation in another study with investigational drug or device within the 30 days preceding and during the present study;\n* Have any indication that would require Magnetic Resonance Imaging (MRI)\n* Is the investigator himself, his\u002Fher family members, employees or other dependent persons.",{"count":20,"type":21},[24],"This clinical trial aims to assess the preliminary safety and efficacy of Epidural Electrical Stimulation (EES) therapy in managing lower urinary tract dysfunction in individuals with sub-acute or chronic spinal cord injury (SCI). The study evaluates the therapy's potential to improve urinary function and prevent neurogenic detrusor overactivity, ultimately seeking to enhance quality of life for individuals with SCI.",[189,106],"Spinal Cord Injuries (SCI)","2025-07-09",{"date":192,"type":37},"2025-07-14",{"date":194,"type":37},"2025-03-10",{"date":196,"type":21},"2027-02",{"name":43,"class":44},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":45},"100447796","epidural-electrical-stimulation-to-restore-hemodynamic-stability-and-trunk-control-in-people-with-spinal-cord-injury-100447796","NCT05111093","Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury","HemON","Inclusion Criteria:\n\n* 18 years of age or older\n* Must provide and sign the Informed Consent prior to any study related procedures\n* Spinal cord injury lesion level between C3 and T6 (inclusive)\n* SCI ≥ 1month\n* Confirmed orthostatic hypotension\n* Stable medical, physical and psychological condition as considered by the investigators\n* Able to understand and interact with the study team in French or English\n* Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments\n\nExclusion Criteria:\n\n* SCI related to a neurodegenerative disease\n* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery\n* The inability to withhold antiplatelet\u002Fanticoagulation agents perioperatively\n* History of myocardial infarction or cerebrovascular event within the past 6 months\n* Other conditions that would make the subject unable to participate in testing in the judgement of the investigators\n* Clinically significant mental illness in the judgement of the investigators\n* Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment\n* Presence of significant pressure ulcers\n* Recurrent urinary tract infection refractory to antibiotics\n* Presence of indwelling baclofen or insulin pump\n* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding,\n* Lack of safe contraception for women of childbearing capacity,\n* Intention to become pregnant during the course of the study,\n* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,\n* Participation in another study with investigational drug within the 30 days preceding and during the present study,\n* Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons.",{"count":206,"type":21},20,[24],"The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (\\>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.",[136],[106],"2025-05-26",{"date":213,"type":37},"2025-05-30",{"date":215,"type":37},"2021-11-29",{"date":217,"type":21},"2030-12-31",{"name":43,"class":44},""]