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Spinal Cord Injuries and Disorders (SCI/D)NCT07423949

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

A study testing Cerebellar theta burst stimulation, Cervical transcutaneous spinal cord stimulation and Functional task practice in people with Spinal Cord Injuries and Disorders (SCI/D), run by University of British Columbia at 1 site in Canada.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Cerebellar theta burst stimulation, Cervical transcutaneous spinal cord stimulation and Functional task practice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
1 Mar 2026to 28 Feb 2031
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 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

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

Raza Malik, PhD contact

604-827-3369

boyd.lab@ubc.ca

Canada1 site
  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z3

    Jordan Lab Manager, 604-822-6886, brocato@mail.ubc.ca

Other trials in Canada

About this study

Official title: Combining Non-invasive Brain and Spinal Cord Stimulation for Improving Arm and Hand Function Following Spinal Cord Injury.

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.

Being tested
Cerebellar theta burst stimulation, Cervical transcutaneous spinal cord stimulation, Functional task practice
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
Medical subject headings
Spinal Cord Injuries, Disease

What participants receive

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

  • Cerebellar theta burst stimulationDevice

    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.

  • Cervical transcutaneous spinal cord stimulationDevice

    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

  • Functional task practiceBehavioural

    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.

Study groups in NCT07423949
Study groupRoleWhat they receive
Cerebellar TBS + Cervical tSCSActive comparatorParticipants 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.
Receives: Device: Cerebellar theta burst stimulation; Device: Cervical transcutaneous spinal cord stimulation; Behavioral: Functional task practice
Cervical tSCS onlyActive comparatorParticipant will recieve 60 min of active cervical transcutaneous spinal cord stimulation only 3x/week for 8 weeks, alongside functional task practice.
Receives: Device: Cervical transcutaneous spinal cord stimulation; Behavioral: Functional task practice
Sham Cerebellar TBS + Sham Cervical tSCSSham comparatorParticipants 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.
Receives: Device: Cerebellar theta burst stimulation; Device: Cervical transcutaneous spinal cord stimulation; Behavioral: Functional task practice

What is being measured

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

  1. 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.

    Measured: From enrollment to the end of stimulation at 8 weeks

  2. 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.

    Measured: Baseline and after 8 weeks of stimulation

  3. 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).

    Measured: Baseline and after 8 weeks of stimulation

Secondary outcomes (4)
  1. Arm and hand sensorimotor control

    Arm and hand sensorimotor control will be indexed using Kinarm standard tests. Specifically, by the task score and path: length ratio during a four target visually guided reaching task using the Kinarm End-Point Lab (BKIN Technologies Ltd., Kingston, ON, Canada). These metrics take into account the spatial and temporal components of reaching, providing nuanced information regarding motor control strategies. We will also characterize proprioceptive sense by using an arm position matching task on the Kinarm and quantifying absolute matching error.

    Measured: Baseline and after 8 weeks of stimulation

  2. Corticospinal excitability (Motor Evoked Potentials [MEPs]):

    To characterize cortical excitability, we will index resting motor threshold for corticospinal tracts. We will use single-pulse TMS delivered using a figure-of-eight coil connected to the Magstim SuperRapid2 Plus-1 stimulator (Magstim Rapid II System , Magstim Company Ltd., GB, Class II License No 69773). MEPs will be recorded from the first dorsal interosseous (FDI) muscle (Bagnoli™, Delsys Inc., Natick, USA). The motor hotspot, which is the region where a single-pulse stimulation elicits the largest and most consistent MEP in the most-affected hand, will be identified and recorded. A neuronavigation system, will be used to ensure the consistent targeting of the hotspot across sessions. Resting motor threshold is the stimulator output that elicits an MEP >50μV in 5 of 10 trials at rest. We will quantify MEP amplitudes and latencies to evaluate corticospinal excitability.

    Measured: Baseline and after 8 weeks of stimulation

  3. Cerebellar-brain inhibition (CBI)

    Cerebellar influences on motor evoked potentials can be assessed using a dual TMS coil approach. CBI will be elicited by applying a conditioning pulse (CS) over the lateral cerebellum (midpoint between the inion and the mastoid targets the lateral cerebellum)16 using a double-cone coil before a test stimulus (TS) over the contralateral motor cortex using a figure-of-eight coil (Magstim Rapid II System , Magstim Company Ltd., GB, Class II License No 69773). The interstimulus interval between CS and TS will be 5ms-7ms to maximize the inhibitory effect. TS intensity will be set to the minimum intensity that elicits MEPs with an average peak-to-peak amplitude of 0.5-1 mV. CS intensity will be set to 100% RMT, with a maximum intensity cut-off at 80% maximum stimulator output (MSO) to avoid discomfort. Ten conditioned and 15 unconditioned MEPs will be collected. The amplitude of the conditioning MEPs will be expressed as a ratio of the mean unconditioned stimuli.

    Measured: Baseline and after 8 weeks of stimulation

  4. Spinal reflex excitability (H-reflex):

    H-reflex testing will be conducted by obtaining surface EMG responses (Bagnoli™, Delsys Inc., Natick, USA, not a medical device [research purposes only]) from the upper limb muscles (e.g., extensor/flexor carpi radialis, FDI) in response to median/radial nerve stimulation (Bio-logic aep system - stimulator, facial digitimer ds7a, natus medical incorporated dba excel-tech ltd (xltek), Oakville, Canada, Class II License No 85645). To generate a H-Reflex recruitment curve (input-output curve), square-wave pulses will be delivered starting at sub-threshold intensities for eliciting an H-reflex. Stimulations of progressively higher intensity will be delivered until a plateau in the peak-to-peak amplitude of the M-Wave is observed. We will calculate Hmax/Mmax ratio to index the percentage of the motoneuron pool that is activated.

    Measured: Baseline and after 8 weeks of stimulation

Timeline

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

  1. First posted20 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Nov 2030 (estimated)
  4. Study completion28 Feb 2031 (estimated)

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07423949
Sponsor's protocol ID
H25-02621
Status last verified
Feb 2026
First submitted
29 Jan 2026
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request. Requests will be subject to approval by the study investigators, completion of a data-use agreement, and compliance with participant consent and institutional ethics approvals. Data will be available beginning after publication of the primary study results. Requests should be directed to the study principal investigator.

Questions about this trial

What is this clinical trial studying?

A study testing Cerebellar theta burst stimulation, Cervical transcutaneous spinal cord stimulation and Functional task practice in people with Spinal Cord Injuries and Disorders (SCI/D), run by University of British Columbia 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 9 inclusion and 6 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 20 Feb 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 Raza Malik, PhD (604-827-3369, boyd.lab@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility outcomes (time frame: From enrollment to the end of stimulation at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Feb 2026.

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