Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury

NCT07375745 | Not Yet Recruiting

• 1 other identifier: CRIR 2025-2082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Spinal Cord Injury Subacute; Locomotion; Gait Disorder, Sensorimotor; Gait Disorders

Keywords

Spinal Cord Injury; Neuromodulation; Locomotion; tSCS; Non-invasive; Transcutaneous; Gait; Transcranial Magnetic Stimulation; Subacute; Artificial Intelligence; AI; Lower Limb; Gait training; Walking; Transcutaneous spinal stimulation; Tonic stimulation; Combined gait training and neuromodulation

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Motor Score

  Lower Extremity Motor Score (LEMS), derived from the ASIA Impairment Scale, is scored from 0 to 50, with higher scores indicating better motor function.

  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

Secondary Outcomes (7)

• Transspinal evoked potentials

  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

• Cortical excitability

  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

• Muscle strength

  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

• Spasticity

  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

• Sensory function

  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

Other Outcomes (2)

• Somatosensory changes following gait training combined with tSCS using EEG

  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

• Evaluation of safety and feasibility

  Throughout the entier duration of the participation : From day 0 to one month after day 20.

Study Arms (2)

Gait training alone (n=20)

SHAM COMPARATOR

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.

Other: Protocol 1: Gait training combined with a sham stimulation

Gait training + tSCS (n=20)

EXPERIMENTAL

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.

Other: Protocol 2: Gait training combined with an effective tSCS

Interventions

Protocol 2: Gait training combined with an effective tSCS OTHER

The training will be conducted using either the G-EO System (ReHa Technology) or a treadmill/overground with participants secured by a bodyweight support system (Biodex) to reduce bodyweight and prevent falls. Participants will complete 20 training sessions over a periode of 5 to 6 weeks. Each session will last up to 40 minutes, with rest periods if needed in case of performance decline. Each session will begin with a warm-up phase (5 minutes) to evaluate the condition of the participant and to ensure safety. On the G-EO System, this consists of using Passive Mode, which fully compensates for the participant's motor deficits. On the treadmill, the warm-up involves full hand assistance to guide gait. In experimental group, participants will combined gait training with tSCS at T11-L2, sets to individualized parameters determined to facilitate lower limbs movement generation.

Gait training + tSCS (n=20)

Protocol 1: Gait training combined with a sham stimulation OTHER

The training will be conducted using either the G-EO System (ReHa Technology) or a treadmill/overground with participants secured by a bodyweight support system (Biodex) to reduce bodyweight and prevent falls. Participants will complete 20 training sessions over a periode of 5 to 6 weeks. Each session will last up to 40 minutes, with rest periods if needed in case of performance decline. Each session will begin with a warm-up phase (5 minutes) to evaluate the condition of the participant and to ensure safety. On the G-EO System, this consists of using Passive Mode, which fully compensates for the participant's motor deficits. On the treadmill, the warm-up involves full hand assistance to guide gait. In sham-group, participants will combined gait training with a sham stimulation sets at sensory threshold, providing the perception of stimulation without activating locomotor spinal circuits.

Gait training alone (n=20)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead
• Mitacs: collaborator

Study Sites (1)

Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)

Montreal, Quebec, H3S 2J4, Canada

Location

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MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dorothy Barthélemy, pht, PhD

CONTACT

514-343-6111; dorothy.barthelemy@umontreal.ca

Nicolas Hoang Quang, MSc

CONTACT

nicolas.hoang.quang@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic double-blind randomized controlled trial

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)