RecruitingNot Applicable

Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation

Switzerland3 participantsStarted 2023-05-22

Plain-language summary

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. In 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.

Who can participate

Age range

18 Years – 75 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.

* Must provide Informed Consent as documented by signature (Appendix Informed Consent Form), * Must be at least 18 years old and no older than 75 years old at the time of enrolment, * Must be suffering from non-progressive traumatic cervical 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 be severely impaired in his upper limb function as determined by the investigator, * Must have sustained the injury at least 6 months before signing the consent form, * Must be able to understand and interact with the study team in French or English, * Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments, * Must use safe contraception for women of childbearing capacity, * Must not be pregnant nor breast feeding, * Must not have history of severe autonomic dysreflexia, * Must not have brain damage, * Must not have history of epilepsy, * Must not have spinal stenosis, * Must not have gastrointestinal ulcers in the last five years, * Must not have any psychological disorder, * Must not have the intention to become pregnant during the course of the study, * Must not be known or suspected of drug or alcohol abuse, * Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study, * Must not have previously …

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

Number of treatment-related serious adverse events (SAEs).

Timeframe: Through completion of the study 12 months

Trial details

NCT IDNCT05665998

SponsorEcole Polytechnique Fédérale de Lausanne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Jocelyne Bloch, MD

+41 79 556 29 51 jocelyne.bloch@chuv.ch

View on ClinicalTrials.gov More Cervical Spinal Cord Injury trials