Epidural Stimulation for Upper Extremity Function (NCT06437548) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Epidural Stimulation for Upper Extremity Function
20 participantsStarted 2024-09
Plain-language summary
Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.
At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.
The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.
Who can participate
Age range
18 Years – 65 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:
* Age ≥18 years and ≤65
* Provides informed consent
* History of upper extremity nerve transfer \> 6 months prior to enrollment
* Completion of standard post-nerve transfer occupational therapy
* Baseline upper extremity strength of \< 5/5 grade with the MRC
* Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
* Willing and able to adhere to the study protocol
Exclusion Criteria:
* Central nervous system (CNS) malignancy
* A contraindication to the SCS procedure
* Diagnosis that precludes the patient from full participation in the protocol
* A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
* Botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment
* For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
* Other factors that prevent participation in the opinion of the surgeon-principal investigator
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.