Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury (NCT07375745) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury
Canada40 participantsStarted 2026-10-01
Plain-language summary
Spinal cord injury (SCI) often results in partial or complete loss of movement. In the subacute phase (\< 6 months), the central nervous system shows increased potential for neuroplasticity, making it more responsive to rehabilitation and external stimulation. Standard care in rehabilitation centers relies on activity-based therapy (ABT), which uses intensive, task-specific training to promote recovery. Although ABT can improve mobility, its effects are often limited due to the nature of SCI and the indirect activation of neural circuits.
Recent findings suggest that adding transcutaneous spinal cord stimulation (tSCS) to ABT in chronic SCI (\> 12 months) can enhance lower-limb motor recovery. This study will evaluate whether combining tSCS with gait training is safe and feasible in individuals with subacute SCI and whether it improves lower-limb motor outcomes compared with gait training alone.
The investigators hypothesize that pairing gait training with tSCS early after injury will be safe and feasible and that tSCS delivered during gait training will augment leg muscle activation and lead to greater functional improvements. The study will also assess the feasibility, safety and tolerability of implementing this combined intervention in a intensive functional rehabilitation setting.
Who can participate
Age range
16 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:
* paraplegic or quadriplegic participants with a subacute spinal cord injury (sSCI), defined as the stage of spinal cord damage occuring between 1 week and 6 months post-injury
* above 16 years old
* have a lesion between C1 - L2
* be considered as AIS A to D
* be able to stay at least 10 minutes standing with or without assistance
* can provide informed consent (no cognitive deficits by MoCA)
* be able to follow instructions in French or English
Exclusion Criteria:
* pacemaker
* active cancer on stimulation site or metastatic cancer
* unhealed wound, scar or pain which makes positioning of the electrodes impossible
* participants with specific contraindications to TMS (epilepsy, non-union cranial fracture and increased intracranial pressure) will be able to participate in the study, but will not receive TMS
* chronic and severe neuropathic pain
* pharmacology or implants that may impede with rehabilitation or spinal stimulation
* pregnancy
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.
1This trial is listed as 'not yet recruiting' — can you find out when it's expected to open and whether it makes sense for me to wait for it, or whether I should pursue other options now?
2The trial focuses on combining spinal stimulation with gait training to improve leg movement after a spinal cord injury — given my specific injury level and how recently it happened, do you think my situation matches what this study seems to be targeting?
3The main outcome being measured is the Lower Extremity Motor Score — can you explain what that score means for my situation today, and what kind of improvement would actually matter for my daily life?
4Since this trial has no listed phase, which often means it's exploring how a technique works rather than confirming it's effective, what does that tell us about how much is already known about the safety and benefit of combining spinal stimulation with gait training?
5Are there standard rehabilitation approaches or other existing treatments I should be trying right now during the subacute period that I shouldn't delay while waiting for this trial to open?
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
Lower Extremity Motor Score
Timeframe: 3 time frames : At day 0 (= baseline, prior to the first training session), up to one week after day 20 (= the last training session) and one month after day 20
Trial details
NCT IDNCT07375745
SponsorCentre for Interdisciplinary Research in Rehabilitation of Greater Montreal