Combining brain stimulation with cycling therapy for spinal cord injury recovery
Exploring the Effect of Non-invasive Brain Stimulation Paired With Functional Electrical Stimulation to Improve Lower Extremity Function Following Incomplete Spinal Cord Injury
This study is testing if combining brain stimulation with cycling therapy can help people with incomplete spinal cord injuries improve their walking and movement better than using either treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05975606 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effects of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on improving lower extremity function in individuals with incomplete spinal cord injury. Participants will undergo a six-week training program, attending sessions twice a week, where they will receive either active or sham brain stimulation followed by electrical stimulation during cycling. The study aims to determine if the combination of these therapies leads to better outcomes, such as increased walking speed, compared to each intervention alone. Assessments will include clinical tests of gait, balance, and strength, utilizing advanced measurement technologies.
Who should consider this trial
Good fit: Ideal candidates are adults with motor incomplete spinal cord injuries classified as C or D on the AIS, who can walk independently for 10 meters.
Not a fit: Patients with other orthopedic or neurological conditions affecting lower extremity function or contraindications to the therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery of mobility and independence for patients with incomplete spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with each individual therapy, but this combined approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult * having motor incomplete SCI with level C or D on the American Spinal Injury Association Impairment Scale (AIS) with the lesion at any level of the cord resulting from either traumatic or non-traumatic etiology who are at least one-year post-injury. * having non-progressive SCI * being able to walk independently for 10 meters without help from another person Exclusion Criteria: * other orthopedic or neurological implications that affect the lower extremity function * contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures, sever contractures, extreme osteoporosis or osteoarthritis) * contraindications to rTMS (e.g., metal implants, history of seizure, cochlear implants)
Where this trial is running
London, Ontario
- Parkwood Institute — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Janelle Unger, PhD
- Email: janelle.unger@uwo.ca
- Phone: +1-519-646-6100
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.