Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabil… (NCT06773286) | Clinical Trial Compass
RecruitingNot Applicable
Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury
United States30 participantsStarted 2024-04-08
Plain-language summary
The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are:
* Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation?
* How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery.
Participants will:
* Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins/session over 2 weeks.
* Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.
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.
Inclusion Criteria:
* must be at least 18 years of age.
* must have had a spinal cord injury for less than or equal to 8 weeks.
* must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).
* must have some degree of motor dysfunction in the hand (bilateral UE motor score \<25).
* must be medically stable enough to participate in activity-based recovery training.
* must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.
* must have ability to understand and the willingness to sign an informed consent.
Exclusion Criteria:
* have a history of seizures, head trauma and/or cognitive deficit
* have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
* have a pressure sore or skin issues.
* have severe spasticity.
* in medically unstable condition.
* have a history of illicit drug abuse.
* have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.
* unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).
* unable to meet the attendance requirements.
* currently enrolled in another interventional research study.
* unable to follow instructions and maintain alertness during assessments and training.
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 of pain before and after daily intervention
Timeframe: From the beginning to the end of each intervention session at 30 minutes
2
Change of skin integrity before and after daily intervention session
Timeframe: From the beginning to the end of each intervention session at 30 minutes
3
Study completion rate
Timeframe: From enrollment to the post-intervention assessment at 3 weeks