Noninvasive spinal cord stimulation to improve arm function
Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study
This study is testing whether a new type of electrical stimulation can help improve arm function in people with spinal cord injuries or strokes when combined with therapy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT06596369 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous electrical stimulation (tcES) on upper extremity function in individuals with spinal cord injuries and stroke. It aims to explore how different stimulation parameters, such as electrode placement and frequency, influence neural excitability and motor function. Participants will undergo a combination of tcES and activity-based therapy, with assessments to evaluate improvements in upper extremity function. The study employs a comprehensive set of neurophysiological techniques to link stimulation effects with functional outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 75 with cervical spinal cord injuries or upper extremity motor dysfunction post-stroke.
Not a fit: Patients with acute spinal cord injuries or those with severe motor dysfunction who cannot participate in rehabilitation activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance upper extremity function in patients with spinal cord injuries and stroke.
How similar studies have performed: Previous studies have shown promise with invasive spinal cord stimulation, but the noninvasive approach being tested here is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: SCI cohort: * individuals aged 18 to 75 years of age who have suffered a spinal cord injury * cervical level injury (C3 to C8) * at least 1-year post-injury * for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening Stroke cohort: * individuals aged 18-75 years of age who have suffered any type of stroke resulting in upper extremity motor dysfunction with partially preserved motor function * ≥ 6 months post-stroke * At least 4 months since last BoNT injection for treatment of spasticity or any other condition or ≤ 2 months after study completion * for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening Exclusion Criteria: * pregnant women * aphasia or dysphasia * spasticity grade Modified Ashworth Scale ≥ 3 Transcranial magnetic stimulation-specific exclusion criteria (both cohorts) * participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps * participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head * participants with a history of seizures or epilepsy * participants taking any medication which may reduce seizure threshold
Where this trial is running
Edmonton, Alberta and 1 other locations
- Glenrose Rehabilitation Hospital — Edmonton, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Jessica D'Amico, PhD — University of Alberta
- Study coordinator: Jessica D'Amico, PhD
- Email: damico1@ualberta.ca
- Phone: 7807357917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.