NCT Number: NCT07375745
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.
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H3S 2J4, Canada
Dorothy Barthelemy, pht, PhD
CONTACT
514-340-2085 ext. 3049
Nicolas Hoang Quang, MSc, PhD student
CONTACT
Nicolas Hoang Quang, MSc, PhD student
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
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.
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
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.
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 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.
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 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.
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 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.
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
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.
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 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.
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
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.
Time frame: Throughout the entier duration of the participation : From day 0 to one month after day 20.
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.
Contact information is provided by the study sponsor or research team.
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Other
Combined Gait Training and Transcutaneous Spinal Cord Stimulation to Enhance Lower Limbs Motor Recovery After Subacute SCI
Acronym: CIMELocomotion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04460872
Androgen Deficiency, Bone Diseases
Gainesville, Florida, United States
View Trial DetailsNCT03096197
Ambulation Difficulty, Central Nervous System Diseases
West Orange, New Jersey, United States
View Trial DetailsNCT05470478
Amyotrophic Lateral Sclerosis, Brain Diseases
Providence, Rhode Island, United States
View Trial DetailsNCT07725952
Autonomic Nervous System Diseases, Cardiovascular Diseases
Yangsan, Gyeongsangnam-do, South Korea
View Trial Details