Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb R… (NCT06243952) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation
Switzerland3 participantsStarted 2024-05-03
Plain-language summary
The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of lower limbs in participants with chronic spinal cord injury suffering from mobility impairment.
The goal is to establish a direct bridge between the motor intention of the participant and the the spinal cord below the lesion, which should not only improve or restore voluntary control of legs movement and support immediate locomotion, but also promote neurological recovery when combined with neurorehabilitation.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures,
. Must be at least 18 years old and no older than 60 years old at the time of enrolment,
. Must be suffering from non-progressive traumatic spinal cord injury,
. Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,
. Must have completed primary standard of care rehabilitation,
. Must have stable medical, physical and psychological condition as considered by the investigator,
. Must be lesioned at T10 or above, based on AIS level determination by the investigator, with preservation of conus function,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Preliminary safety
Timeframe: Through study completion (implantation up to end of study - average of 1 year)