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.
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
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
Parallel
Protocol 1: Gait training combined with a sham stimulation
Other interventionThe 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.
Protocol 2: Gait training combined with an effective tSCS
Other interventionThe 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.
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.
Transspinal evoked potentials
The transspinal evoked potentials (TEPs) are muscle responses (Soleus, Tibialis Anterior, Vastus Lateralis and Biceps Femoris) recorded by electromyography (EMG) after tSCS. For each muscle, the resting motor threshold (RMT), the lowest intensity to elicit a motor response, will be measured. Additionally, normalized TEPmax (TEPmax/Mmax ratio) will be calculated to quantify the proportion of the maximal muscle response elicited by tSCS relative to the maximal direct motor response (Mmax). This ratio provides an index of spinal excitability and the effectiveness of stimulation in activating motor circuits.
Cortical excitability
Transcranial magnetic stimulation (TMS) over the motor cortex will be used to assess corticospinal tract excitability. The latency and amplitude of motor evoked potentials (MEPs), as well as the active and resting motor threshold of the Tibialis Anterior muscle, will be measured.
Muscle strength
Muscle strength will be evaluated using a handheld dynamometer (MicroFET), with measurements expressed in kilograms (kg). Higher values indicate greater muscle strength. Nine movements will be tested bilaterally : hip abduction, hip extension, hip flexion, knee extension, knee flexion, ankle dorsiflexion, ankle eversion, ankle inversion and ankle plantarflexion.
Spasticity
Spasticity in the lower limbs will be assessed after the intervention using the Modified Ashworth Scale by a trained physical therapist. The examiner will passively move the limb through its full range of motion at a constant speed and rate the resistance encountered. The test is scored on a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with higher scores indicating greater levels of spasticity.
Somatosensory changes following gait training combined with tSCS using EEG
Tibial nerve stimulation will be applied and responses will be recorded by electroencephalogram (EEG) prior to and following the intervention. Evaluation of the latency and amplitude of somatosensory evoked potential (SSEP) will be realized.
Evaluation of safety and feasibility
The investigators aim to evaluate if combining transcutaneous spinal cord stimulation with task-specific gait training is feasible early after the lesion is safe and feasible. For safety, the investigators are going to monitored adverse events and all participants will fill a qualitative questionnaire. This questionnaire will notably evaluate how the participant felt safe during the whole study (assessments and training sessions). Feasibility is assessed through recruitment and retention rates, % completion of expected number of sessions.
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