Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation

NCT07361627 | Not Yet Recruiting DMC

• 1 other identifier: CRIR 2024-2080
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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:

• 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 mental imagery 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.

Conditions

Spinal Cord Injury Cervical; Spinal Cord Injury, Acute; Spinal Cord Injury (Quadraplegia)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

• Grasp and Release Test

  3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).

• Dermatome (sensory) test

  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

  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

  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

  3 time points: Pre-intervention (Day 0, prior to the first training session), Post-intervention (+/-1 week) and one-month post-intervention (+/- 1 week).

Study Arms (2)

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.

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.

Other: Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation

Interventions

Protocol 1: Combination of activity-based therapy and sham spinal cord stimulation OTHER

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 begin with a mental imagery exercise in which participants imagine performing a daily activity (e.g., drinking coffee in a café), followed by therapist-selected activities. 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.

Also known as: Sham stimulation

Activity-based therapy with sham spinal stimulation (n=20)

Protocol 2: Combination of activity-based therapy and facilitatory transcutaneous spinal cord stimulation OTHER

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 begin with a mental imagery exercise in which participants imagine performing a daily activity (e.g., drinking coffee in a café), followed by therapist-selected activities. 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.

Also known as: tSCS

Activity-based therapy with facilitatory spinal stimulation (n=20)

Eligibility Criteria

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

You may qualify if:

• quadraplegic participants with a subacute spinal cord injury (sSCI), defined as the stage of spinal cord damage occurring between 1 week and 6 months post-injury, that fall within the period of at least one year post-injury
• years old or above
• have a lesion between above T2
• residual upper limb movement
• have injury level according to ASIA A to D
• hospitalized in the hospital linked with the research center at Gingras Lindsay Rehabilitation Institute of Montreal, 6300 Darlington, Montreal
• can provide informed consent (no severe cognitive deficits by MoCA)
• be able to follow instructions in French or English

You may not qualify if:

• have a pacemaker
• have active cancer on stimulation site or metastatic cancer
• have unstable health conditions
• have 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

Sponsors & Collaborators

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

Study Sites (1)

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

Montreal, Quebec, H3S 2J4, Canada

Location

Related Publications (15)

• 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.

  PMID: 18566941 BACKGROUND

• Steele 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.

  PMID: 35732141 BACKGROUND

• Manson 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.

  PMID: 36212800 BACKGROUND

• Dimitrijevic 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.

  PMID: 3490313 BACKGROUND

• Sadowsky 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.

  PMID: 19489091 BACKGROUND

• Murray 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.

  PMID: 30845251 BACKGROUND

• Kalsi-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.

  PMID: 25229734 BACKGROUND

• Wuolle 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.

  PMID: 8201183 BACKGROUND

• Velstra 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.

  PMID: 23895137 BACKGROUND

• Sullivan 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.

  PMID: 21164120 BACKGROUND

• Molad 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.

  PMID: 33410389 BACKGROUND

• Tefertiller 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.

  PMID: 36004322 BACKGROUND

• Gopaul 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.

  PMID: 39927575 BACKGROUND

• Mulcahey 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.

  PMID: 15001979 BACKGROUND

• Marino 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.

  PMID: 18581663 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Dorothy Barthelemy, pht., PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorothy Barthelemy, pht., Ph.D

CONTACT

+1 514-343-6111; dorothy.barthelemy@umontreal.ca

Marika Demers, erg., Ph.D

CONTACT

514-343-6111; marika.demers@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Clinical outcomes assessors and all participants are masked till the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study model is a double-blind randomized controlled trial (RCT).

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): August 9, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)