Cervical Transcutaneous SCS for TBI (NCT07147816) | Clinical Trial Compass
TerminatedNot Applicable
Cervical Transcutaneous SCS for TBI
Stopped: The study was terminated due to administrative and logistical constraints following the Principal Investigator's transfer to another institution.
United States14 participantsStarted 2025-11-26
Plain-language summary
The goal of this study is to test the effects of non-invasive electrical stimulation of the spinal cord (called transcutaneous spinal cord stimulation, or tSCS) on arm and hand movement in people with motor impairments after a traumatic brain injury (TBI). Specifically, tSCS will be delivered using adhesive electrode pads placed on the skin over the upper back. The research team will measure how tSCS affects strength, movement control and muscle spasticity using different tests. Results of this study will help develop future treatments using an implanted (invasive) form of spinal cord stimulation to improve arm and hand function, helping people with TBI become more independent and improve their quality of life.
Who can participate
Age range
21 Years – 70 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:
TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
* Participants must have a suffered a traumatic brain injury resulting in impairments in arm and hand motor function at least one year prior to enrollment.
* Participants must be between the ages of 21 and 70 years old.
HEALTHY CONTROL SUBJECTS:
* Participants must have full range of motion in their upper limbs;
* Participants must be between the ages of 21 and 70 years old.
Exclusion Criteria:
TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
* Participants with severe behavioral or cognitive impairments (e.g., aphasia, apraxia, visual neglect) that could preclude their ability to participate in the study.
* Participants diagnosed with Paroxysmal Sympathetic Hyperactivity (PSH);
* Participants with post-TBI heterotopic ossification or tendon contractures that restricts passive range of motion of upper limb joints;
* Participants with uncontrolled epilepsy or untreated seizure disorders;
* Participants with implanted electronic devices, such as pacemakers and spinal cord stimulators;
* Participants taking benzodiazepine for spasticity;
* Participants with serious disease or disorder (ex. neurological condition other than TBI, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study.
* Female participants must not be pregnant or breast feeding.
* Evaluation to sign consent form score \<12.
HEALTHY CONTROL SUBJECTS:
\- Participants who have any seriou…
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
Strength
Timeframe: Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)