Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI (NCT07595497) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI
Singapore24 participantsStarted 2027-01-01
Plain-language summary
he goal of this clinical trial is to learn if combined brain and spinal cord stimulation using TMS-tSCS can improve leg strength and walking recovery in adults with chronic incomplete spinal cord injury.
The main questions it aims to answer are:
Does combined TMS-tSCS improve lower limb motor function more than tSCS alone? Is combined TMS-tSCS safe and does it improve walking speed, independence, muscle activity, spasticity, and nerve pathway function?
Researchers will compare combined TMS-tSCS with tSCS alone with sham TMS to see if adding brain stimulation leads to better recovery than spinal stimulation alone.
Participants will:
Attend 32 treatment sessions over 16 weeks. Receive either combined TMS-tSCS or tSCS with sham TMS. Undergo assessments of leg strength, walking speed, daily function, muscle stiffness, muscle activity, and nerve pathway function before and after treatment.
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 18-65 years at enrolment
* Chronic traumatic spinal cord injury, defined as ≥12 months post-injury
* Incomplete spinal cord injury, AIS grade C or D
* Neurological level of injury from C2 to L1
* Baseline Lower Extremity Motor Score (LEMS) \>10 points
* Medically stable
* Able to provide informed consent
* Able to commit to the full study duration
* Able to attempt the 10-Meter Walk Test and 6-Minute Walk Test, with or - without assistive devices and standby assistance
Exclusion Criteria
* History of seizures or epilepsy
* Implanted electronic devices, such as: Pacemaker, Cochlear implant, Deep brain stimulator, Spinal cord stimulator, Metallic implants in the head or spine
* Pregnancy or planned pregnancy
* Active psychiatric disorder or cognitive impairment
* Concomitant neurological conditions, such as: Stroke, Traumatic brain injury and Neuropathy
* Skin breakdown at electrode sites
* Current participation in another clinical trial
* History of skull surgery or craniotomy
* Use of medications that alter cortical excitability within the past 2 weeks
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.