Using Non-invasive Brain and Spinal Cord Stimulation to Improve Arm and Hand Function After Spinal Cord Injury

NCT07423949 | Not Yet Recruiting

• 1 other identifier: H25-02621
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical spinal cord injury (SCI) disrupts communication between the brain and spinal circuits, affecting voluntary movement control and contributing to arm and hand impairments, the top recovery priority for people with tetraplegia. Although rehabilitation and emerging neuromodulation approaches can support meaningful gains, many individuals experience persistent limitations in reaching and grasping. Current noninvasive stimulation strategies typically target the brain OR the spinal cord alone, despite strong reciprocal interactions between these structures. Cervical transcutaneous spinal cord stimulation (tSCS) can enhance upper limb function. Cerebellar stimulation, given its key role in sensorimotor integration and modulation of corticospinal excitability, represents a promising but underexplored therapeutic target. Theta burst stimulation (TBS), a rapid form of repetitive transcranial magnetic stimulation (TMS), induces lasting changes in cortical excitability and may promote associative plasticity when paired with spinal cord stimulation. This double-blind, randomized, sham-controlled pilot trial (n=24) will evaluate the feasibility, preliminary efficacy, and mechanisms of combined cerebellar TBS + cervical tSCS in people with chronic cervical SCI (AIS B, C or D). Participants will either receive cerebellar TBS + cervical tSCS, tSCS only, or sham stimulation while engaging in functional task practice such as pinching and grasping 3x/week for 8 weeks. Feasibility outcomes include adherence, retention, and safety. Efficacy will be assessed using the GRASSP strength sub-score and KINARM-based measures of sensorimotor control. Mechanistic outcomes will assess changes in cortical and spinal cord functional connectivity using resting state fMRI, corticospinal excitability using motor evoked potentials, and spinal excitability using the H reflex. Findings will establish whether combined cerebellar TBS and cervical tSCS is feasible, safe, and capable of enhancing upper limb recovery.

Conditions

Spinal Cord Injuries and Disorders (SCI/D)

Keywords

Spinal cord injury; Transcutaneous Spinal Cord Stimulation; Cerebellar Theta Burst Stimulation; Arm and Hand Function; Upper Limb Motor Control; Transcranial Magnetic Stimulation; Neuroimaging; Neurophysiology

Outcome Measures

Primary Outcomes (3)

• Feasibility outcomes

  Feasibility, which will be assessed through adherence, recruitment, retention, and adverse event rates across all groups. We will specifically document session numbers, dates and times, as well as the frequency and severity of skin irritations, abnormal blood pressure responses (e.g., autonomic dysreflexia), cardiac responses (e.g., tachycardia, bradycardia) and any symptoms. Participant safety will be monitored throughout the intervention via regular skin integrity checks and cardiovascular recordings (blood pressure and heart rate) throughout each session.

  From enrollment to the end of stimulation at 8 weeks

• Upper limb strength

  Change in upper limb strength from pre- to post-intervention using the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) strength sub-score. The GRASSP evaluates three domains: strength manual muscle testing of key upper limb muscles), sensibility (light touch and pinprick discrimination), and prehension, which includes both a qualitative analysis of grasp patterns and a performance-based component (GRASSP-Prehension Performance) that assesses functional use of the hand during object manipulation tasks. Strength will be the primary dependent measure from this measure.

  Baseline and after 8 weeks of stimulation

• Sensorimotor network connectivity

  Change in functional connectivity strength of the cortical sensorimotor network from pre- to post- intervention using resting-state functional MRI (fMRI). We will use a Philips Ingenia Elition 3.0T MRI scanner with a 32-channel sensitivity head coil to scan brain and a separate 20 channel dStream head/neck coil for cervical spinal cord. We will collect T1 and resting state functional MRI scans of both brain and cervical spinal cord at baseline and post-intervention. Resting state functional MRI will be acquired to characterize functional reorganization of the brain and/or spinal cord driven by cerebellar TBS + cervical tSCS (or tSCS alone) alongside functional task practice. Brain and spinal cord functional connectivity: We will characterize properties of the sensorimotor network, particularly global efficiency, which represents the overall capacity that the network has to transfer information (i.e., quantifies the extent to which nodes of the network are integrated).

  Baseline and after 8 weeks of stimulation

Secondary Outcomes (4)

• Arm and hand sensorimotor control

  Baseline and after 8 weeks of stimulation

• Corticospinal excitability (Motor Evoked Potentials [MEPs]):

  Baseline and after 8 weeks of stimulation

• Cerebellar-brain inhibition (CBI)

  Baseline and after 8 weeks of stimulation

• Spinal reflex excitability (H-reflex):

  Baseline and after 8 weeks of stimulation

Other Outcomes (3)

• Neurological function and injury severity

  Baseline and after 8 weeks of stimulation

• Short-form (36) Health Survey (SF-36):

  Baseline and after 8 weeks of stimulation

• Autonomic Dysfunction following SCI (ADFSCI) questionnaire:

  Baseline and after 8 weeks of stimulation

Study Arms (3)

Cerebellar TBS + Cervical tSCS

ACTIVE COMPARATOR

Participants will recieve 60 min of active cervical transcutaneous spinal cord stimulation with intermittent bouts of active Cerebellar theta burst stimulation 3x/week for 8 weeks, alongside functional task practice.

Device: Cerebellar theta burst stimulation; Device: Cervical transcutaneous spinal cord stimulation; Behavioral: Functional task practice

Cervical tSCS only

ACTIVE COMPARATOR

Participant will recieve 60 min of active cervical transcutaneous spinal cord stimulation only 3x/week for 8 weeks, alongside functional task practice.

Device: Cervical transcutaneous spinal cord stimulation; Behavioral: Functional task practice

Sham Cerebellar TBS + Sham Cervical tSCS

SHAM COMPARATOR

Participants will recieve 60 min of sham cervical transcutaneous spinal cord stimulation with intermittent bouts of sham Cerebellar theta burst stimulation 3x/week for 8 weeks, alongside functional task practice.

Device: Cerebellar theta burst stimulation; Device: Cervical transcutaneous spinal cord stimulation; Behavioral: Functional task practice

Interventions

Cerebellar theta burst stimulation DEVICE

Theta burst stimulation (TBS) is a pattern of repetitive transcranial magnetic stimulation that will be delivered over the lateral hemisphere of the cerebellum. Sham TBS will be delivered using a sham coil over the cerebellum.

Cerebellar TBS + Cervical tSCS; Sham Cerebellar TBS + Sham Cervical tSCS

Cervical transcutaneous spinal cord stimulation DEVICE

Non-invasive electrical stimulation at 30Hz will be delivered through 2 round electrodes placed over the cervical vertebrae to target the cervical spinal cord. Sham cervical tSCS will involve briefly increasing stimulation intensity to the sensory threshold, followed by reducing the intensity to zero for the remainder of the session

Cerebellar TBS + Cervical tSCS; Cervical tSCS only; Sham Cerebellar TBS + Sham Cervical tSCS

Functional task practice BEHAVIORAL

All participants will complete 60-minute sessions of functional task practice three times per week for eight weeks, delivered concurrently with either real or sham stimulation. Following functional task practice guidelines, training will consist of repetitive, goal-directed upper-limb activities designed to promote functional independence in everyday tasks.

Cerebellar TBS + Cervical tSCS; Cervical tSCS only; Sham Cerebellar TBS + Sham Cervical tSCS

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 19 years of age and no older than 75 years at the time of enrollment. Previous research has demonstrated the safety and efficacy of stimulation-based interventions in adults up to 75 years of age. The lower age limit reflects the legal age for independent informed consent in British Columbia.7,8
• Non-progressive cervical SCI from C2-C8 inclusive
• AIS classification B, C or D
• Indicated for upper extremity training procedures by the participant's treating physician, occupational therapist, or physical therapist
• GRASSP-Prehension score ≥10 or GRASSP-Strength score ≥30
• Minimum 12 months after injury (i.e., chronic SCI)
• If prescribed anti-spasticity or pain medications, must be at a stable dose for at least 4 weeks before commencing study procedures
• Stable management of spinal cord related clinical issues (e.g., spasticity management, autonomic dysreflexia)
• Capable of providing informed consent

You may not qualify if:

• Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations, such as severe neuropathic pain, depression, mood disorders or other cognitive disorders
• Has been diagnosed with autonomic dysreflexia that is severe, unstable and uncontrolled
• History of additional neurologic disease, such as stroke, multiple sclerosis and traumatic brain injury
• History of seizures (e.g. epilepsy).
• Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
• Participant has undergone electrode implantation surgery.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Raza Malik, PhD

CONTACT

604-827-3369; boyd.lab@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): February 28, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)