Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury
(CIMELocomotion Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants with spinal cord injury (SCI) classified as AIS A-D will receive active transcutaneous spinal cord stimulation (tSCS) combined with robotic-assisted, treadmill, or overground gait training. The stimulation intensity will be individually adjusted to facilitate voluntary movement generation and enhance activation of spinal circuits involved in locomotion. The type of gait training will be determined based on the severity of the injury and the participant's ability to generate locomotor movements. Each participant will complete 20 training sessions, delivered four times per week over approximately five weeks. The gait training sessions will be individualized and task-specific, emphasizing repetitive stepping practice to promote locomotor learning and engage spinal and supraspinal networks responsible for walking.
Participants with spinal cord injury (SCI) classified as AIS A-D will receive sham transcutaneous spinal cord stimulation (tSCS) combined with robotic-assisted, treadmill, or overground gait training. The sham stimulation will reproduce the sensory sensation of active tSCS without eliciting effective spinal activation, ensuring participant blinding. The type of gait training will be determined based on the severity of the injury and the participant's ability to generate voluntary or assisted locomotor movements. Each participant will complete 20 training sessions, delivered four times per week over approximately five weeks. The gait training sessions will be individualized and task-specific, emphasizing repetitive stepping practice to promote locomotor learning and engage spinal and supraspinal networks involved in walking.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Lead Sponsor
Mitacs
Industry Sponsor
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