Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury
About 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...
Included participants
What’s involved
Type
Details
This study is lead by Dorothy Barthélemy (Ph.D, pht, Principal Investigator) and Nicolas Hoang Quang (M.Sc, Ph.D student) and collaborators, Marina Martinez (Ph.D), Marco Bonizzato (Ph.D) and Diana Zidarov (Ph.D). Spinal cord injury (SCI) often results in partial or complete loss of motor function, greatly impacting independence and quality of life. During the subacute phase of recovery, defined as the first 6 months after injury, the central nervous system enters a period of heightened neuroplasticity in which it becomes especially responsive to rehabilitation and external stimulation. This critical window offers an opportunity to maximize motor recovery through targeted interventions. In rehabilitation centers, the current standard of care focuses on activity-based therapy (ABT). ABT consists of intensive, repetitive and task-specific exercises designed to activate neural circuits below the level of injury, strengthen spared pathways and promote the formation of new neural connections. Although ABT has demonstrated benefits, it is frequently insufficient to restore functional walking, even when delivered intensively. As part of the CIME (Clinic for Intensive and Neuromodulation for Individuals with Spinal Cord Injury) Program, this study aims not to remain passive observers of the participant's nervous system as it attempts to generate the sensory inputs required for motor recovery. Instead, the investigators aim to actively enhance these inputs through targeted neuromodulation. Recent evidence in chronic SCI suggests that combining ABT with transcutaneous spinal cord stimulation (tSCS) may augment the activity of spinal circuits involved in movement. tSCS is a non-invasive form of electrical stimulation applied to the skin over the spine, capable of activating dorsal root afferents and increasing the excitability of spinal networks. In this study, tSCS is used to provide direct, patterned sensory input to the CNS to potentially improve motor output during gait training. This pragmatic randomized clinical trial will evaluate the safety and feasibility of combining task-specific gait training-delivered using robotic-assisted gait devices, treadmill-based therapy, or overground walking, with tSCS delivered Neurotrac Myoplus (FDA-approved stimulator) beginning as early as 4 to 6 weeks post-injury, within an intensive functional rehabilitation program. The study will also examine whether the addition of tSCS enhances lower-limb motor recovery in individuals with subacute SCI compared with gait training alone. The investigators hypothesize that delivering tSCS during gait training early after injury will be safe and feasible, and that the combined intervention will increase leg muscle activation and lead to greater functional improvements than gait training alone. Feasibility, safety and tolerability of the combined approach will be systematically assessed to inform future clinical applications and larger-scale trials.
Potential benefits
Main benefits
Standing/walking/mobility
Additional benefits
Arm/hand function
General health
Sensory function
Spasticity
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Recruiting
- Trial start date
- 27 Jan 2025
- Organisation
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Trial recruitment status
- Recruiting
- Trial start date
- 27 Jan 2025
- Organisation
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more