Spinal Cord Injury CervicalCIME_upperlimbNCT07361627
Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation
A study testing Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation in people with Spinal Cord Injury Cervical and Spinal Cord Injury, Acute, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial summary
The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury Cervical, Spinal Cord Injury, Acute, Spinal Cord Injury (Quadraplegia)
- What is being tested?
- Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 9 Dec 2028
- 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
- Traumatic and non-traumatic spinal cord injury
- Receiving in-patient rehabilitation
- 16 years old or above
- American Spinal Injury Association (ASIA) grade A to D
- Neurological injury level between C5 and T2
- Residual upper limb motor impairments
Who cannot join
- Cardiac pacemaker
- Active cancer at the stimulation site or metastatic cancer
- Unstable lesion or clinical condition (e.g. respiratory issues)
- Electrode placement is impossible due to unhealed wound or significant local pain
- Other Neurological condition (e.g. Stroke, Parkinson's)
- Chronic liver or kidney disease
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- Uncontrolled psychiatric condition
- Life expectancy < 6 months
- Inability to provide informed consent (i.e., severe cognitive impairment, dementia, or Alzheimer's disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)
Montreal, Quebec, H3S 2J4
Dorothy Barthelemy, pht, PhD, 514-343-7712, dorothy.barthelemy@umontreal.ca
Sujata Sinha, M.Tech., Ph.D, 514-605-2320, sujata.sinha@umontreal.ca
About this study
Official title: Improving Upper Limb Motor Control With Spinal Stimulation
The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.
The main questions relevant to this study are:
Read more
- Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI?
- Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions?
- Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?
In this study, participants will:
- Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements)
- Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and motor control strengthening exercises with a therapist.
- Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.
Researchers will compare the assessment outcomes across the three time points.
Read the detailed description
This RCT study is led by Dorothy Barthélemy (Ph.D, pht, Principal Investigator (PI)), Marika Demers (Ph.D, erg., co-PI), Diana Zidarov (Ph.D, co-PI) and Sujata Sinha (PhD, postdoctoral fellow, project lead). Collaborator includes Victoria Duda (PhD).
Population: individuals with SCI with injury level between C5 and T2, falling into American Spinal Injury Association (ASIA) categories A to D, in the sub-acute phase, and of minimum age of 16 years. These participants are in-patients admitted in the Institut de réadaptation Gingras-Lindsay de Montréal, Canada.
Participants will be randomized (1:1 ratio) into two equal groups, ABT + tSCS and ABT + sham stimulation and stratified based on ASIA level, age and sex.
During the training session, the ABT + tSCS group will receive ABT combined with tSCS. The tSCS will be delivered using surface electrode placed between C4 and T1 as a cathode and self-adhesive surface electrodes placed in the clavicular region on both sides as anodes. tSCS will deliver tonic pulses (30 - 100 Hz) and at an intensity that facilitates voluntary movements (usually 15 mA and up), determined prior to the first training session. Each ABT session will include 5 parts:
- 'Motor control strengthening: equipped with an electronic goniometer, participants control muscle contraction of one joint by following a pattern on a computer screen.
- Cardiovascular warm-up exercises: using equipment that will allow the participant to train their cardiovascular system.
- Weight bearing and stretching exercises: exercises to prepare their upper body muscles for the strengthening exercises.
- Muscle strengthening exercises: exercises to increase their strength, with adapted equipment if necessary.
- Activity-based exercises: exercises composed of repetitive that are present in the participant's daily life.
In the ABT+ sham stimulation group, intensity will be set at sensory threshold that will not facilitate any movement (usually 2-3mA). The ABT will be similar to the other group.
Prior to the training, clinical tests will be conducted to assess assess their muscle strength, sensations, and the quality of movements participants can make with their arms. Specifically, the primary measure will consist of the Upper Extremity Motor Score from the with American Spinal Injury Association Impairment Exam. The secondary clinical measures will include the following assessments: the Prehension subtest of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP-version 2) , Monofilaments test, Sensory function of the upper limb dermatomes from C4 to T1, Grip and pinch strength with a dynamometer, Proprioception subtest of the Fugl Meyer Assessment, the finger-to-nose test and the Tetraplegic Upper Limb Activity Questionnaire (TUAQ). More details of the measures are in the Outcome Measures section.
For neurophysiological measures, electrophysiological assessments will include transspinal evoked potential (TEP), motor evoked potentials (MEPs) using transcranial magnetic stimulation (TMS) and somatosensory evoked potentials (SSEPs) using electroencephalogram (EEG).
These assessments will be conducted before the training, immediately after the training and one month later.
As for the experiment, 40 participants will be recruited, as determined by a priori power analysis.
For the neuroplasticity evaluation, TEP, TMS and EEG will be used.
- To assess the excitability of spinal pathways, the non-invasive procedure of single-pulse transcutaneous spinal stimulation (tSCS) will be used. Participants will be comfortably seated in a chair or in their wheelchair. Self-adhesive surface electrodes will be placed over the cervical spine, with the cathode (Dura stick plus double wire, Dura stick, USA) over C4-T1 and anodes over the external part of the clavicles (TENS electrodes, ROHVEMJ). Single-pulse tSCS will be delivered using a constant-current stimulator (DS8R, Digitimer, UK) to induce Transspinal evoked potentials (TEPs). Responses will be recorded from surface electromyography. More details of the measurement are in the Outcome Measures section.
- To assess changes along the corticospinal tract (motor cortex projections to the spinal cord), a magnetic field using the TMS will be applied to the primary motor cortex (M1) over the representation area of the contralateral bicep brachii muscle (this is the target muscle). This response will be recorded painlessly using surface electromyography (EMG) electrodes placed over the targeted muscle. The entire evaluation, including setup, will take approximately one hour. The responses evoked by TMS, that is, the motor evoked potentials, (MEPs) will be compared across the 3 time frames in each group. Particularly, latency and peak-to-peak amplitude of MEPs will be measured. More details of the measurement are in the Outcome Measures section. 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 take part in the TMS assessment..
- To assess changes in brain mechanisms, particularly those related to sensory function, EEG recordings will be performed using Brain Vision's 32-electrode cap, with the Fz electrode used as the reference. Recordings will be obtained using a Brain Vision 32-channel EEG cap referenced to Fz. The median nerve of the upper limb (at the wrist site) will be electrically stimulated to elicit cortical responses. The entire evaluation duration will be for 90 minutes including the setup.
EEG activity from C3 and C4 corresponding to the contralateral sensorimotor cortex, will be analyzed, focusing on the N20 and P25 somatosensory evoked potential (SSEP) components, which occur approximately 20 ms and 25 ms post-stimulus, respectively. The N20-P25 complex reflects transmission through ascending somatosensory pathways.
N20 refers to the negative-deflecting SSEP peaking approximately 20 ms after the onset of electrical stimulation at the median nerve. P25 follows the N20, deflecting in a positive direction peaking around 25 ms after stimulus onset. Together, these form the N20-P25 complex, which reflects the transmission along ascending neuronal pathways. In addition to these two SSEPs that occur in the early time-window, P50 and the N70 SSEPs that peak approximately around 50ms and 70 ms , respectively, after the stimulus onset. The amplitude and latency of the SSEPs will be compared across the 3 time frames in each group. In addition to C3 and C4, the neighboring electrode regions will also be inspected to identify any additional SSEPs that may emerge. More details of the measurement are in the Outcome Measures section.
- Being tested
- Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation, Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation
- Keywords
- Spinal cord injury, Sub-acute, Neuromodulation, transcutaneous Spinal Cord Stimulation, Activity-based therapy, Upper extremity motor score, Rehabilitation, Electroencephalography, EEG, Somatosensory evoked potential, Transcranial Magnetic Stimulation, Motor evoked potential, Clinical assessment, Neuroplasticity
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol 1: Combination of activity-based therapy and sham spinal cord stimulationOther
Also called Sham stimulation
The training session for the sham group comprises of activity-based therapy along with sham stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will consist of cardiovascular training, stretching, weight-bearing, strengthening and controlled strengthening and task-oriented training. Participants will receive transcutaneous spinal cord stimulation set at sensory threshold intensity (i.e., below the threshold that facilitates voluntary movement of the limb; usually 2-3 mA intensity), delivered simultaneously with training.
Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulationOther
Also called tSCS
The training session for the experimental group comprises of activity-based therapy along with facilitatory stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will consist of cardiovascular training, stretching, weight-bearing, strengthening and controlled strengthening and task-oriented training. Participants will receive transcutaneous spinal cord stimulation set at a target intensity that facilitates voluntary upper limb movement (usually between 10 and 25 mA) in the participants.
| Study group | Role | What they receive |
|---|---|---|
| Activity-based therapy with sham spinal stimulation (n=20) | Sham comparator | Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive sham transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage.
For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. Receives: Other: Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation |
| Activity-based therapy with facilitatory spinal stimulation (n=20) | Experimental | Participants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive real-intensity transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage.
For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. Individualized tSCS parameters (30-80Hz, 0-90mA, biphasic 400us pulse square) will be used to facilitate upper limb movement. Receives: Other: Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Motor Score (UEMS)
This will be used for assessing the motor function, that is, the strength and functionality of the muscles involved in movement. It helps determine the severity of motor impairments in patients with cervical lesions and is used to track recovery and assess outcome during inpatient rehabilitation. It has high inter-rater and intra-rater reliability. It also has high validity as an impairment measure and has moderate validity for predicting real-world functional independence.
The test evaluates five movements of each arm, namely, elbow flexion, wrist extension, elbow extension, middle finger flexion, and little finger abduction. The participant is asked to perform these movements either actively or passively, depending on their ability. These are scored on a scale from 0 (no movement) to 5 (full function). Thus, the higher score reflects improvement in the motor function across the three time frames.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Secondary outcomes (9)
The Prehension subtest of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP- version 2)
This test will be used to assess the hand function in participants, particularly their grasping ability and object manipulation. This includes two components: prehension ability (PA) and prehension performance (PP).
PA evaluates the capacity to perform different grasp patterns, including cylindrical, lateral pinch, and tip pinch grasps. Each hand is assessed separately and scored on a scale from 0 to 4, with 4 being the normal voluntary control of the wrist and fingers during grasp execution.
PP assesses the ability to complete functional tasks requiring grasp, manipulation, and release of objects of various shapes and sizes. Each hand is evaluated separately, and task performance is scored from 0 to 5, with 5 being the most successful task completion using the intended grasp pattern.
Higher total scores indicate better hand function and prehension ability.
The subtest has excellent test-retest reliability (ICC = 0.93-0.98) and excellent inter-rater reliability (ICC = 0.95-0.96).
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Upper-limb sensory score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
This will be used to assess the sensory level of the participant by evaluating the ability to feel stimuli and to differentiate between sharp and dull sensations (pinprick test) on specific regions of the skin corresponding to spinal nerve segments.
The summed sensory scores (light touch + pinprick) have good to excellent inter- and intra-rater reliability. So, we will use the summed scores. The test has good validity for classifying lesion level and severity, moderate for predicting function, and has limited sensitivity (not sensitive to subtle changes) compared to electrophysiological or quantitative tests.
Light touch and pinprick sensation are first demonstrated on the participant's cheek. The participant, seated with eyes closed, is tested using light touch with tissue or cotton (assessing large A fibers) and pinprick with a pin or toothpick (assessing smaller A-delta and C fibers for superficial pain) at six test sites. The sensation is reported by them.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Monofilament test
This will be used to quantify and to assess the sensory function, particularly for detecting areas of sensory loss or abnormal sensation (neuropathic pain). This test has high validity and inter-and intra tester reliability in participants with chronic cervical spinal cord injury.
The test is conducted using Semmes-Weinstein monofilaments. With eyes closed, the participant is asked to report whether they can feel the pressure when a monofilament is applied to different regions of the upper limb. The threshold at which the stimulus is perceived is recorded (5.88, 5.07, 4.56, 4.08, 3.22). Specific regions are assessed depending on the nerve: the pulp of the middle finger for the median nerve, the pulp of the little finger for the ulnar nerve, the first dorsal space of the hand between the thumb and index finger and the lateral epicondyle at the extensor compartment for the radial nerve, and the deltoid region for the axillary nerve.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Force (Grip and Pinch Strength) test
This will be used to assess grip and pinch strength which are used in daily tasks involving hand function. The Pinch strength test has good to excellent reliability for neurological conditions and has strong to very strong correlations with grip strength. It has a good validity.
The Grip strength has an excellent test-retest reliability in SCI. It shows a very high intra- and inter-rater reliability if standardized protocols (same dynamometer, position, instructions) are followed. It has a good validity.
Grip strength is measured using a dynamometer, with the participant seated and the elbow flexed at 90 degrees. The participant must squeeze the device as hard as possible for 3 trials; the average of these trials is calculated. Pinch strength is measured using a pinch gauge, where the participant pinches an object between the thumb and index finger with maximum effort. Again, the average of 3 trials is taken.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Proprioception
This test is used to the assess the ability to sense the position of the limbs in space, important for evaluating proprioceptive deficits that can affect balance and coordination.
It has a moderate overall and inter-rater reliability and depends strongly on the therapist's technique. Intra-rater reliability is better but is variable as participants can have fatigue or guess. Test-retest reliability is lower than that of dermatomes or motor scores.
It has a limited validity; construct validity is supported and concurrent validity shows moderate correlation with function; criterion validity is limited.
The participant is blinded while the therapist moves their upper limb (shoulder, elbow, and wrist) to a specific position and asks them to replicate the position with the opposite limb or to report the position. Results are reported as the difference between the actual and replicated positions.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Coordination test
This test is used to assess the ability to perform smooth, controlled movements, critical for fine motor tasks (e.g. writing, buttoning a shirt).
Its reliability is generally low to moderate: intra-rater reliability is variable as it depends on the therapist scoring, inter-rater reliability is moderate at best, and test-retest reliability is limited since coordination can fluctuate with fatigue, spasticity, or attention.
Validity is also limited, with moderate construct validity, low to moderate concurrent validity, and limited criterion validity.
The standard finger-to-nose test is used: the participant is asked to touch a target with the index finger and then their nose, repeating the movement five times at a fast but comfortable pace. The therapist observes for tremors, uncoordinated movements, delays, and scores performance using a 12-point scale per side that considers precision, fluidity, arm movement, and trunk stability.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Transspinal evoked potentials (TEPs)
TEPs will be measured through single-pulse transcutaneous spinal stimulation (tSCS). The cathode (Dura stick plus double wire, Dura stick, USA) will be positioned at the midline over C4-T1 and anode over the external part of the clavicles (TENS electrodes, ROHVEMJ). Single-pulse tSCS will be delivered using a constant-current stimulator (DS8R, Digitimer, UK) with monophasic square-wave pulses of 1ms at a frequency of 0.2Hz to induce TEPs. Responses will be recorded from surface electromyography. Stimulation intensity will be gradually increased from 0 to evoke a potential in all, or in the maximum number of upper limb muscles recorded. Two of the outcome measures will be for each muscle: the motor threshold, i.e., the lowest intensity inducing 5/10 stimulation responses; and the recruitment curve. The third measure will include amplitude, latency, and duration of the TEP at 120% of the motor threshold, determined for the myotome that showed the smallest response.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Transcranial magnetic stimulation (TMS)- motor evoked potentials
This neurophysiological assessment will be done to test if there are neuroplastic changes because of the ABT + tSCS training. TMS will be applied to the primary motor cortex (M1) over the representation area of the contralateral bicep brachii muscle (this is the target muscle). A figure-8 shaped coil will deliver the magnetic field to activate motor nerves, leading to the activation of the target muscle. This response will be recorded painlessly using surface electromyography electrodes placed over the targeted muscle. Four 5-minute stimulation sets, each separated by 2-minute rest periods, will be conducted. The entire evaluation, including setup, will take approximately one hour. The responses evoked by TMS, that is, the motor evoked potentials, (MEPs) will be compared across the 3 time frames in each group. Quantitative parameters will include MEP amplitude (magnitude), and latency, serving as indicators of cortico-spinal excitability changes pre- and post-intervention.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Electrophysiology (EEG)-Somatosensory evoked potentials (SSEPs)
This test will also be done for neuroplastic evaluation. SSEPs are time-locked EEG responses reflecting sensory pathway conduction from peripheral nerves to the somatosensory cortex. Participants will be comfortably seated in a chair. For each arm, the median nerve will be stimulated using surface electrodes placed near the wrist to elicit upper-limb SSEPs. EEG will be recorded with a 32-channel cap (Brain Vision Recorder 2.0) following the 10-20 system, referenced to Fz. During a 10-minute session for each arm, 1800 stimuli (3 Hz, 0.001 s duration) will be delivered at 5% of the maximal flexor carpi radialis response. EEG signals will be sampled at 5000 Hz and analyzed in BrainVision Analyzer using filtering and averaging. Primary regions of interest include C3/C4 and adjacent electrodes (Cz, C1/2, FCz). The expected SSEPs are N20 (~20 ms) and P25 (~25 ms). The presence, amplitude, and latency of the N20-P25 complex will serve as measures of somatosensory pathway excitability.
Measured: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion9 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study model is a double-blind randomized controlled trial (RCT).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Barthelemy, pht., PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361627
- Sponsor's protocol ID
- CRIR 2024-2080
- Acronym
- CIME_upperlimb
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lynskey JV, Belanger A, Jung R. Activity-dependent plasticity in spinal cord injury. J Rehabil Res Dev. 2008;45(2):229-40. doi: 10.1682/jrrd.2007.03.0047.
PubMed 18566941Steele AG, Manson GA, Horner PJ, Sayenko DG, Contreras-Vidal JL. Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. J Neural Eng. 2022 Jul 1;19(4). doi: 10.1088/1741-2552/ac7b4b.
PubMed 35732141Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.
PubMed 36212800Dimitrijevic MR, Illis LS, Nakajima K, Sharkey PC, Sherwood AM. Spinal cord stimulation for the control of spasticity in patients with chronic spinal cord injury: II. Neurophysiologic observations. Cent Nerv Syst Trauma. 1986 Spring;3(2):145-52. doi: 10.1089/cns.1986.3.145.
PubMed 3490313Sadowsky CL, McDonald JW. Activity-based restorative therapies: concepts and applications in spinal cord injury-related neurorehabilitation. Dev Disabil Res Rev. 2009;15(2):112-6. doi: 10.1002/ddrr.61.
PubMed 19489091Murray LM, Knikou M. Transspinal stimulation increases motoneuron output of multiple segments in human spinal cord injury. PLoS One. 2019 Mar 7;14(3):e0213696. doi: 10.1371/journal.pone.0213696. eCollection 2019.
PubMed 30845251Kalsi-Ryan S, Beaton D, Curt A, Popovic MR, Verrier MC, Fehlings MG. Outcome of the upper limb in cervical spinal cord injury: Profiles of recovery and insights for clinical studies. J Spinal Cord Med. 2014 Sep;37(5):503-10. doi: 10.1179/2045772314Y.0000000252.
PubMed 25229734Wuolle KS, Van Doren CL, Thrope GB, Keith MW, Peckham PH. Development of a quantitative hand grasp and release test for patients with tetraplegia using a hand neuroprosthesis. J Hand Surg Am. 1994 Mar;19(2):209-18. doi: 10.1016/0363-5023(94)90008-6.
PubMed 8201183Velstra IM, Bolliger M, Baumberger M, Rietman JS, Curt A. Epicritic sensation in cervical spinal cord injury: diagnostic gains beyond testing light touch. J Neurotrauma. 2013 Aug 1;30(15):1342-8. doi: 10.1089/neu.2012.2828.
PubMed 23895137Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.
PubMed 21164120Molad R, Alouche SR, Demers M, Levin MF. Development of a Comprehensive Outcome Measure for Motor Coordination, Step 2: Reliability and Construct Validity in Chronic Stroke Patients. Neurorehabil Neural Repair. 2021 Feb;35(2):194-203. doi: 10.1177/1545968320981943.
PubMed 33410389Tefertiller C, Rozwod M, VandeGriend E, Bartelt P, Sevigny M, Smith AC. Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Front Rehabil Sci. 2021;2:740307. doi: 10.3389/fresc.2021.740307. Epub 2022 Jan 4.
PubMed 36004322Gopaul U, Bayley MT, Kalsi-Ryan S. Combined Activity-Based Therapy and Cervical Spinal Cord Stimulation: Active Ingredients, Targets and Mechanisms of Actions to Optimize Neurorestoration of Upper Limb Function After Cervical Spinal Cord Injury. Physiother Res Int. 2025 Apr;30(2):e70036. doi: 10.1002/pri.70036.
PubMed 39927575Mulcahey MJ, Betz RR, Kozin SH, Smith BT, Hutchinson D, Lutz C. Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques. Spinal Cord. 2004 Mar;42(3):146-55. doi: 10.1038/sj.sc.3101573.
PubMed 15001979Marino RJ, Jones L, Kirshblum S, Tal J, Dasgupta A. Reliability and repeatability of the motor and sensory examination of the international standards for neurological classification of spinal cord injury. J Spinal Cord Med. 2008;31(2):166-70. doi: 10.1080/10790268.2008.11760707.
PubMed 18581663
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Upper Limb Motor Control With Spinal Stimulation
- ClinicalTrials.gov ID
- NCT07361627
- Acronym / sponsor ID
- CIME_upperlimb / CRIR 2024-2080
- Keywords
- Spinal cord injury, Sub-acute, Neuromodulation, transcutaneous Spinal Cord Stimulation, Activity-based therapy, Upper extremity motor score, Rehabilitation, Electroencephalography
- 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
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 9 Dec 2028 (estimated)
- First posted
- 23 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.
The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.
The main questions relevant to this study are:
- Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI?
- Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions?
- Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?
In this study, participants will:
- Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements)
- Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and motor control strengthening exercises with a therapist.
- Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.
Researchers will compare the assessment outcomes across the three time points.
Detailed description
This RCT study is led by Dorothy Barthélemy (Ph.D, pht, Principal Investigator (PI)), Marika Demers (Ph.D, erg., co-PI), Diana Zidarov (Ph.D, co-PI) and Sujata Sinha (PhD, postdoctoral fellow, project lead). Collaborator includes Victoria Duda (PhD).
Population: individuals with SCI with injury level between C5 and T2, falling into American Spinal Injury Association (ASIA) categories A to D, in the sub-acute phase, and of minimum age of 16 years. These participants are in-patients admitted in the Institut de réadaptation Gingras-Lindsay de Montréal, Canada.
Participants will be randomized (1:1 ratio) into two equal groups, ABT + tSCS and ABT + sham stimulation and stratified based on ASIA level, age and sex.
During the training session, the ABT + tSCS group will receive ABT combined with tSCS. The tSCS will be delivered using surface electrode placed between C4 and T1 as a cathode and self-adhesive surface electrodes placed in the clavicular region on both sides as anodes. tSCS will deliver tonic pulses (30 - 100 Hz) and at an intensity that facilitates voluntary movements (usually 15 mA and up), determined prior to the first training session. Each ABT session will include 5 parts:
- 'Motor control strengthening: equipped with an electronic goniometer, participants control muscle contraction of one joint by following a pattern on a computer screen.
- Cardiovascular warm-up exercises: using equipment that will allow the participant to train their cardiovascular system.
- Weight bearing and stretching exercises: exercises to prepare their upper body muscles for the strengthening exercises.
- Muscle strengthening exercises: exercises to increase their strength, with adapted equipment if necessary.
- Activity-based exercises: exercises composed of repetitive that are present in the participant's daily life.
In the ABT+ sham stimulation group, intensity will be set at sensory threshold that will not facilitate any movement (usually 2-3mA). The ABT will be similar to the other group.
Prior to the training, clinical tests will be conducted to assess assess their muscle strength, sensations, and the quality of movements participants can make with their arms. Specifically, the primary measure will consist of the Upper Extremity Motor Score from the with American Spinal Injury Association Impairment Exam. The secondary clinical measures will include the following assessments: the Prehension subtest of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP-version 2) , Monofilaments test, Sensory function of the upper limb dermatomes from C4 to T1, Grip and pinch strength with a dynamometer, Proprioception subtest of the Fugl Meyer Assessment, the finger-to-nose test and the Tetraplegic Upper Limb Activity Questionnaire (TUAQ). More details of the measures are in the Outcome Measures section.
For neurophysiological measures, electrophysiological assessments will include transspinal evoked potential (TEP), motor evoked potentials (MEPs) using transcranial magnetic stimulation (TMS) and somatosensory evoked potentials (SSEPs) using electroencephalogram (EEG).
These assessments will be conducted before the training, immediately after the training and one month later.
As for the experiment, 40 participants will be recruited, as determined by a priori power analysis.
For the neuroplasticity evaluation, TEP, TMS and EEG will be used.
- To assess the excitability of spinal pathways, the non-invasive procedure of single-pulse transcutaneous spinal stimulation (tSCS) will be used. Participants will be comfortably seated in a chair or in their wheelchair. Self-adhesive surface electrodes will be placed over the cervical spine, with the cathode (Dura stick plus double wire, Dura stick, USA) over C4-T1 and anodes over the external part of the clavicles (TENS electrodes, ROHVEMJ). Single-pulse tSCS will be delivered using a constant-current stimulator (DS8R, Digitimer, UK) to induce Transspinal evoked potentials (TEPs). Responses will be recorded from surface electromyography. More details of the measurement are in the Outcome Measures section.
- To assess changes along the corticospinal tract (motor cortex projections to the spinal cord), a magnetic field using the TMS will be applied to the primary motor cortex (M1) over the representation area of the contralateral bicep brachii muscle (this is the target muscle). This response will be recorded painlessly using surface electromyography (EMG) electrodes placed over the targeted muscle. The entire evaluation, including setup, will take approximately one hour. The responses evoked by TMS, that is, the motor evoked potentials, (MEPs) will be compared across the 3 time frames in each group. Particularly, latency and peak-to-peak amplitude of MEPs will be measured. More details of the measurement are in the Outcome Measures section. 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 take part in the TMS assessment..
- To assess changes in brain mechanisms, particularly those related to sensory function, EEG recordings will be performed using Brain Vision's 32-electrode cap, with the Fz electrode used as the reference. Recordings will be obtained using a Brain Vision 32-channel EEG cap referenced to Fz. The median nerve of the upper limb (at the wrist site) will be electrically stimulated to elicit cortical responses. The entire evaluation duration will be for 90 minutes including the setup.
EEG activity from C3 and C4 corresponding to the contralateral sensorimotor cortex, will be analyzed, focusing on the N20 and P25 somatosensory evoked potential (SSEP) components, which occur approximately 20 ms and 25 ms post-stimulus, respectively. The N20-P25 complex reflects transmission through ascending somatosensory pathways.
N20 refers to the negative-deflecting SSEP peaking approximately 20 ms after the onset of electrical stimulation at the median nerve. P25 follows the N20, deflecting in a positive direction peaking around 25 ms after stimulus onset. Together, these form the N20-P25 complex, which reflects the transmission along ascending neuronal pathways. In addition to these two SSEPs that occur in the early time-window, P50 and the N70 SSEPs that peak approximately around 50ms and 70 ms , respectively, after the stimulus onset. The amplitude and latency of the SSEPs will be compared across the 3 time frames in each group. In addition to C3 and C4, the neighboring electrode regions will also be inspected to identify any additional SSEPs that may emerge. More details of the measurement are in the Outcome Measures section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study model is a double-blind randomized controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Activity-based therapy with sham spinal stimulation (n=20) | Sham comparator | Other: Protocol 1: Combination of activity-based therapy and sham spinal cord stimulationParticipants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive sham transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage. For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. |
| Activity-based therapy with facilitatory spinal stimulation (n=20) | Experimental | Other: Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulationParticipants with cervical spinal cord injury (ASIA levels A-D) randomized to this arm will receive real-intensity transcutaneous spinal cord stimulation combined with activity-based therapy. Training will consist of 20 sessions delivered over 6-8 weeks during the subacute stage. For the transcutaneous spinal cord stimulation (tSCS), a single or two self-adhesive cathode electrodes will be placed at the C4 to T1 vertebral levels. A pair of reference electrodes will be placed bilaterally on the external part of the clavicular regions. The stimulation will be set at minimal intensity, sufficient only for the participants to perceive it. Individualized tSCS parameters (30-80Hz, 0-90mA, biphasic 400us pulse square) will be used to facilitate upper limb movement. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Traumatic and non-traumatic spinal cord injury
- Receiving in-patient rehabilitation
- 16 years old or above
- American Spinal Injury Association (ASIA) grade A to D
- Neurological injury level between C5 and T2
Key exclusion criteria (9 listed)
- Cardiac pacemaker
- Active cancer at the stimulation site or metastatic cancer
- Unstable lesion or clinical condition (e.g. respiratory issues)
- Electrode placement is impossible due to unhealed wound or significant local pain
- Other Neurological condition (e.g. Stroke, Parkinson's)
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: Combination of activity-based therapy and sham spinal cord stimulationAlso: Sham stimulationThe training session for the sham group comprises of activity-based therapy along with sham stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will consist of cardiovascular training, stretching, weight-bearing, strengthening and controlled strengthening and task-oriented training. Participants will receive transcutaneous spinal cord stimulation set at sensory threshold intensity (i.e., below the threshold that facilitates voluntary movement of the limb; usually 2-3 mA intensity), delivered simultaneously with training. | Other | Activity-based therapy with sham spinal stimulation (n=20) |
| Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulationAlso: tSCSThe training session for the experimental group comprises of activity-based therapy along with facilitatory stimulation on the spinal cord of the participants. These training sessions will include repetitive, intensive strength training and functional exercises targeting arm and hand (upper limb) movements. Sessions will be delivered by trained physiotherapists and occupational therapists. Each participant will complete 20 sessions over six to eight weeks (three per week), with each session lasting 45 minutes. Breaks will be added, if needed. Training will consist of cardiovascular training, stretching, weight-bearing, strengthening and controlled strengthening and task-oriented training. Participants will receive transcutaneous spinal cord stimulation set at a target intensity that facilitates voluntary upper limb movement (usually between 10 and 25 mA) in the participants. | Other | Activity-based therapy with facilitatory spinal stimulation (n=20) |
Primary outcome
Upper Extremity Motor Score (UEMS)
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
This will be used for assessing the motor function, that is, the strength and functionality of the muscles involved in movement. It helps determine the severity of motor impairments in patients with cervical lesions and is used to track recovery and assess outcome during inpatient rehabilitation. It has high inter-rater and intra-rater reliability. It also has high validity as an impairment measure and has moderate validity for predicting real-world functional independence. The test evaluates five movements of each arm, namely, elbow flexion, wrist extension, elbow extension, middle finger flexion, and little finger abduction. The participant is asked to perform these movements either actively or passively, depending on their ability. These are scored on a scale from 0 (no movement) to 5 (full function). Thus, the higher score reflects improvement in the motor function across the three time frames.
9 secondary outcomes
The Prehension subtest of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP- version 2)
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Upper-limb sensory score of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Monofilament test
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Force (Grip and Pinch Strength) test
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Proprioception
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Coordination test
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Transspinal evoked potentials (TEPs)
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Transcranial magnetic stimulation (TMS)- motor evoked potentials
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
Electrophysiology (EEG)-Somatosensory evoked potentials (SSEPs)
Time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).
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 28 Jul 2026.
- Background: PubMed 18566941Lynskey JV, Belanger A, Jung R. Activity-dependent plasticity in spinal cord injury. J Rehabil Res Dev. 2008;45(2):229-40. doi: 10.1682/jrrd.2007.03.0047.
- Background: PubMed 35732141Steele AG, Manson GA, Horner PJ, Sayenko DG, Contreras-Vidal JL. Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. J Neural Eng. 2022 Jul 1;19(4). doi: 10.1088/1741-2552/ac7b4b.
- Background: PubMed 36212800Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.
- Background: PubMed 3490313Dimitrijevic MR, Illis LS, Nakajima K, Sharkey PC, Sherwood AM. Spinal cord stimulation for the control of spasticity in patients with chronic spinal cord injury: II. Neurophysiologic observations. Cent Nerv Syst Trauma. 1986 Spring;3(2):145-52. doi: 10.1089/cns.1986.3.145.
- Background: PubMed 19489091Sadowsky CL, McDonald JW. Activity-based restorative therapies: concepts and applications in spinal cord injury-related neurorehabilitation. Dev Disabil Res Rev. 2009;15(2):112-6. doi: 10.1002/ddrr.61.
- Background: PubMed 30845251Murray LM, Knikou M. Transspinal stimulation increases motoneuron output of multiple segments in human spinal cord injury. PLoS One. 2019 Mar 7;14(3):e0213696. doi: 10.1371/journal.pone.0213696. eCollection 2019.
- Background: PubMed 25229734Kalsi-Ryan S, Beaton D, Curt A, Popovic MR, Verrier MC, Fehlings MG. Outcome of the upper limb in cervical spinal cord injury: Profiles of recovery and insights for clinical studies. J Spinal Cord Med. 2014 Sep;37(5):503-10. doi: 10.1179/2045772314Y.0000000252.
- Background: PubMed 8201183Wuolle KS, Van Doren CL, Thrope GB, Keith MW, Peckham PH. Development of a quantitative hand grasp and release test for patients with tetraplegia using a hand neuroprosthesis. J Hand Surg Am. 1994 Mar;19(2):209-18. doi: 10.1016/0363-5023(94)90008-6.
- Background: PubMed 23895137Velstra IM, Bolliger M, Baumberger M, Rietman JS, Curt A. Epicritic sensation in cervical spinal cord injury: diagnostic gains beyond testing light touch. J Neurotrauma. 2013 Aug 1;30(15):1342-8. doi: 10.1089/neu.2012.2828.
- Background: PubMed 21164120Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.
- Background: PubMed 33410389Molad R, Alouche SR, Demers M, Levin MF. Development of a Comprehensive Outcome Measure for Motor Coordination, Step 2: Reliability and Construct Validity in Chronic Stroke Patients. Neurorehabil Neural Repair. 2021 Feb;35(2):194-203. doi: 10.1177/1545968320981943.
- Background: PubMed 36004322Tefertiller C, Rozwod M, VandeGriend E, Bartelt P, Sevigny M, Smith AC. Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Front Rehabil Sci. 2021;2:740307. doi: 10.3389/fresc.2021.740307. Epub 2022 Jan 4.
- Individual participant dataSharing planned: No
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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 Barthelemy, pht., PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation in people with Spinal Cord Injury Cervical and Spinal Cord Injury, Acute, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
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 6 inclusion and 9 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 28 Jul 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 Barthelemy, pht., Ph.D (+1 514-343-6111 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?
Upper Extremity Motor Score (UEMS) (time frame: 3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).). 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 NCT07361627, which also lists 16 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 28 Jul 2026.