Spinal Cord InjuryCIMELocomotionNCT07375745

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

A study testing Protocol 2: Gait training combined with an effective tSCS in people with Spinal Cord Injury and Spinal Cord Injury Subacute, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Spinal Cord Injury, Spinal Cord Injury Subacute, Locomotion
What is being tested?: Protocol 2: Gait training combined with an effective tSCS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteCanada
Study dates: 1 Oct 2026to Jul 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dorothy Barthélemy, pht, PhD contact

514-343-6111 ext. 13962

dorothy.barthelemy@umontreal.ca

Nicolas Hoang Quang, MSc contact

nicolas.hoang.quang@umontreal.ca

Canada1 site

Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)
Montreal, Quebec, H3S 2J4
Dorothy Barthelemy, pht, PhD, 514-340-2085 ext. 3049, dorothy.barthelemy@umontreal.ca
Nicolas Hoang Quang, MSc, PhD student, nicolas.hoang.quang@umontreal.ca

Other trials in Canada

About this study

Official title: Combined Gait Training and Transcutaneous Spinal Cord Stimulation to Enhance Lower Limbs Motor Recovery After Subacute SCI

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.

Read the detailed description

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.

Conditions: Spinal Cord Injury, Spinal Cord Injury Subacute, Locomotion, Gait Disorder, Sensorimotor, Gait Disorders
Being tested: Protocol 1: Gait training combined with a sham stimulation, Protocol 2: Gait training combined with an effective tSCS
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
Medical subject headings: Spinal Cord Injuries, Gait Disorders, Neurologic, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Protocol 1: Gait training combined with a sham stimulationOther
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.
Protocol 2: Gait training combined with an effective tSCSOther
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.

Study groups in NCT07375745
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Protocol 2: Gait training combined with an effective tSCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Sensory function will be assessed using the sensory component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Light touch and pinprick sensations will be tested bilaterally across key dermatomes and scored on an ordinal scale. The total sensory score ranges from 0 to 56 (each for light touch and pinprick), with higher scores indicating better preserved sensory function.
Measured: 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 (2)
Light touch and protective sensation will be assessed using Semmes-Weinstein monofilaments. Monofilaments of varying thickness will be applied perpendicularly to specific sites on the plantar surface of the foot or other areas of interest, until the filament bends. Participants will indicate whether they can perceive the touch. Each site will be tested multiple times to ensure reliability. The presence of sensation at thinner filaments indicates better sensory function, whereas inability to detect thicker filaments suggests sensory loss.
Measured: 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
Balance and trunk control
Balance will be assessed using the Modified Functional Reach Test (MFRT). Participants will be asked to reach forward as far as possible without taking a step or losing their balance, while sitting. The distance (in centimeters) reached is measured from the starting position of the fingertips to the maximal forward reach. Each trial will be performed three times and the average distance will be recorded. Higher reach distances indicate better dynamic balance and postural stability.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2026Jul 2029

First posted29 Jan 2026
Study start1 Oct 2026 (estimated)
Primary completionJan 2029 (estimated)
Study completionJul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Pragmatic double-blind randomized controlled trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07375745
Sponsor's protocol ID: CRIR 2025-2082
Acronym: CIMELocomotion
Status last verified: Jul 2026
First submitted: 23 Dec 2025
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cruccu G, Truini A. A review of Neuropathic Pain: From Guidelines to Clinical Practice. Pain Ther. 2017 Dec;6(Suppl 1):35-42. doi: 10.1007/s40122-017-0087-0. Epub 2017 Nov 24.
PubMed 29178033
Rodrigues L, Moncion K, Eng JJ, Noguchi KS, Wiley E, de Las Heras B, Sweet SN, Fung J, MacKay-Lyons M, Nelson AJ, Medeiros D, Crozier J, Thiel A, Tang A, Roig M. Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. Trials. 2022 May 24;23(1):442. doi: 10.1186/s13063-022-06359-w.
PubMed 35610659
Shackleton C, Hodgkiss D, Samejima S, Miller T, Perez MA, Nightingale TE, Sachdeva R, Krassioukov AV. When the whole is greater than the sum of its parts: a scoping review of activity-based therapy paired with spinal cord stimulation following spinal cord injury. J Neurophysiol. 2022 Nov 1;128(5):1292-1306. doi: 10.1152/jn.00367.2022. Epub 2022 Oct 12.
PubMed 36222423
Barthelemy D, Willerslev-Olsen M, Lundell H, Conway BA, Knudsen H, Biering-Sorensen F, Nielsen JB. Impaired transmission in the corticospinal tract and gait disability in spinal cord injured persons. J Neurophysiol. 2010 Aug;104(2):1167-76. doi: 10.1152/jn.00382.2010. Epub 2010 Jun 16.
PubMed 20554839
Barthelemy D, Willerslev-Olsen M, Lundell H, Biering-Sorensen F, Nielsen JB. Assessment of transmission in specific descending pathways in relation to gait and balance following spinal cord injury. Prog Brain Res. 2015;218:79-101. doi: 10.1016/bs.pbr.2014.12.012. Epub 2015 Mar 29.
PubMed 25890133
Megia Garcia A, Serrano-Munoz D, Taylor J, Avendano-Coy J, Gomez-Soriano J. Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Neurorehabil Neural Repair. 2020 Jan;34(1):3-12. doi: 10.1177/1545968319893298. Epub 2019 Dec 20.
PubMed 31858871
Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.
PubMed 26077679
Gerasimenko Y, Gorodnichev R, Puhov A, Moshonkina T, Savochin A, Selionov V, Roy RR, Lu DC, Edgerton VR. Initiation and modulation of locomotor circuitry output with multisite transcutaneous electrical stimulation of the spinal cord in noninjured humans. J Neurophysiol. 2015 Feb 1;113(3):834-42. doi: 10.1152/jn.00609.2014. Epub 2014 Nov 5.
PubMed 25376784
Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
PubMed 26205686
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
PubMed 29877852
Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A; "Psychological Theory" Group. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005 Feb;14(1):26-33. doi: 10.1136/qshc.2004.011155.
PubMed 15692000
Brotherton SS, Saunders LL, Krause JS, Morrisette DC. Association between reliance on devices and people for walking and ability to walk community distances among persons with spinal cord injury. J Spinal Cord Med. 2012 May;35(3):156-61. doi: 10.1179/2045772312Y.0000000012.
PubMed 22507025
Laferriere S, Bonizzato M, Cote SL, Dancause N, Lajoie G. Hierarchical Bayesian Optimization of Spatiotemporal Neurostimulations for Targeted Motor Outputs. IEEE Trans Neural Syst Rehabil Eng. 2020 Jun;28(6):1452-1460. doi: 10.1109/TNSRE.2020.2987001. Epub 2020 Apr 13.
PubMed 32286996
Gill ML, Grahn PJ, Calvert JS, Linde MB, Lavrov IA, Strommen JA, Beck LA, Sayenko DG, Van Straaten MG, Drubach DI, Veith DD, Thoreson AR, Lopez C, Gerasimenko YP, Edgerton VR, Lee KH, Zhao KD. Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia. Nat Med. 2018 Nov;24(11):1677-1682. doi: 10.1038/s41591-018-0175-7. Epub 2018 Sep 24.
PubMed 30250140
Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
PubMed 30382197

Interested in taking part?

Dorothy Barthélemy, pht, PhD

514-343-6111 ext. 13962

dorothy.barthelemy@umontreal.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Tetraplegia/Tetraparesis
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Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
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Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy

All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Gait Training and Transcutaneous Spinal Cord Stimulation to Enhance Lower Limbs Motor Recovery After Subacute SCI
ClinicalTrials.gov ID: NCT07375745
Acronym / sponsor ID: CIMELocomotion / CRIR 2025-2082
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
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
Collaborators: Mitacs
Study start: 1 Oct 2026 (estimated)
Primary completion: Jan 2029 (estimated)
Study completion: Jul 2029 (estimated)
First posted: 29 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Pragmatic double-blind randomized controlled trial

Arm	Type	Receives
Gait training alone (n=20)	Sham comparator	Other: Protocol 1: Gait training combined with a sham stimulationParticipants 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.
Gait training + tSCS (n=20)	Experimental	Other: Protocol 2: Gait training combined with an effective tSCSParticipants 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Protocol 1: Gait training combined with a sham stimulationThe 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.	Other	Gait training alone (n=20)
Protocol 2: Gait training combined with an effective tSCSThe 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.	Other	Gait training + tSCS (n=20)

Primary outcome

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

7 secondary outcomes

Transspinal evoked potentials
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (2)
Time frame: 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
Balance and trunk control
Time frame: 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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Background: PubMed 29178033Cruccu G, Truini A. A review of Neuropathic Pain: From Guidelines to Clinical Practice. Pain Ther. 2017 Dec;6(Suppl 1):35-42. doi: 10.1007/s40122-017-0087-0. Epub 2017 Nov 24.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Dorothy Barthélemy, pht, PhD contact

514-343-6111 ext. 13962

dorothy.barthelemy@umontreal.ca

Nicolas Hoang Quang, MSc contact

nicolas.hoang.quang@umontreal.ca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dorothy Barthélemy, pht, PhD (514-343-6111 ext. 13962, dorothy.barthelemy@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower Extremity Motor Score (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07375745, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.