Using spinal cord stimulation to help improve walking after spinal cord injury
Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury
This study is testing if adding spinal cord stimulation to exoskeleton training can help people with incomplete spinal cord injuries walk better within a year of their injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Craig Hospital Academic / other |
| Locations | 1 site (Englewood, Colorado) |
| Trial ID | NCT05982171 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training on improving motor function in individuals with incomplete spinal cord injury who are within 12 months post-injury. Participants will be randomly assigned to either receive TSCS during their exoskeleton training or to a control group receiving exoskeleton training without TSCS. The study involves 24 one-hour training sessions at Craig Hospital, followed by evaluations of walking ability, lower extremity strength, trunk control, and bowel and bladder function. The goal is to determine if the addition of TSCS enhances recovery compared to exoskeleton training alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are less than 12 months post-injury with incomplete spinal cord injuries classified as AIS C or D.
Not a fit: Patients with unstable cardiac or respiratory issues, recent fractures, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking ability and overall motor function in individuals with spinal cord injuries.
How similar studies have performed: Previous studies have shown promise in using spinal cord stimulation for rehabilitation, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury * AIS C or D classification * 18 years and older * Height 5'0" to 6'4" * Weight 220lbs or less * Sufficient upper extremity strength to manage a stability aide * Medical clearance for high intensity gait training * Walking \<1.46 m/s * Intact skin in on pelvis, lower extremities and back * Passive range of motion at shoulders, trunk, hips, knees \& ankles within functional limits Exclusion Criteria: * Unstable or symptomatic cardiac or respiratory issues * Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study * Received Botox injections to the lower extremities within the last six months * Pregnancy * Cauda Equina injury * Any other issue that in the opinion of the investigator would impact study participation * Non-English Speaking
Where this trial is running
Englewood, Colorado
- Craig Hospital — Englewood, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Clare Morey, MA
- Email: cmorey@craighospital.org
- Phone: 303-789-8621
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.