Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury (NCT04041063) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury
United States6 participantsStarted 2019-07-26
Plain-language summary
The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.
Who can participate
Age range
18 Years – 50 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:
* Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand
* Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
* Chronic lesion (at least 6months after the injury)
* Demonstrate stability of motor examination for at least six months.
* Retain intact innervation within paralyzed target muscles (axon recipient) as determined by electrodiagnostics.
* Have muscles innervated by the nerves to be used for the transfers (axon donors) of MRC grade 4/5 or greater and sufficient innervation as determined by electrodiagnostics.
* Have access to an at home caregiver who can assist with customary postsurgical physical therapy.
* Ability to give informed consent and understand the tasks involved.
Exclusion Criteria:
* Presence of potential risk factor for brain stimulation: history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull.
* History of head trauma and/or cognitive deficit
* Medically unstable
* Contraindicated for nerve transfer surgery.
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
Change in Box and Blocks test score
Timeframe: 1 year post surgery, immediately post training, minus baseline before surgery