Non-invasive Brain and Spinal Cord Stimulation for Spinal Cord Injury

RM
Overseen ByRaza Malik, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

My cervical spinal cord injury from C2 to C8 is stable and not getting worse.
I am able to understand and agree to participate in the study.
5. GRASSP-Prehension score ≥10 or GRASSP-Strength score ≥30
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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

8 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cerebellar theta burst stimulation
  • Cervical transcutaneous spinal cord stimulation
  • Functional task practice

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: Cerebellar TBS + Cervical tSCSActive Control3 Interventions
Group II: Cervical tSCS onlyActive Control2 Interventions
Group III: Sham Cerebellar TBS + Sham Cervical tSCSPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+