Epidural stimulation to improve motor function in spinal cord injury patients
Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
This study is testing if epidural stimulation can help people with spinal cord injuries improve their movement and regain some mobility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Buddhist Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Hualien City) |
| Trial ID | NCT06455137 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of epidural spinal cord stimulation (SCS) on patients with spinal cord injuries (SCI) to enhance motor function. By analyzing electrophysiological responses, the study aims to identify optimal SCS settings that promote limb activity and restore motor abilities through multimodal electrical stimulation and sensory feedback. The goal is to improve nerve plasticity and potentially establish new neural connections, allowing patients to regain mobility and enhance their quality of life post-injury.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 70 with complete or incomplete spinal cord injuries who are at least one year post-injury and are expected to undergo spinal cord stimulation surgery.
Not a fit: Patients with significant cognitive impairments, major depressive disorder, or other serious medical conditions that could interfere with rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies on spinal cord stimulation have shown promising results in improving motor function, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * SCI ASIA: A, B, C,D * Between 20 and 70 year of age * \>1 year post SCI * Complete or incomplete spinal cord injury. * Expected will undergo spinal cord stimulation surgery. * Continued rehabilitation after surgery for spinal cord injury. * Able to comply with procedures and follow up. * Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities Exclusion Criteria: * Have significant cognitive impairment (MMSE\<24). * Had a mental illness within one year or been treated in the past. * Have Major depressive disorder. * Active cancer diagnosis. * Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training. * Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention. * Unable to read and/or comprehend the consent form. * Have concerns about this trial and do not sign consent.
Where this trial is running
Hualien City
- Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Sheng-Tzung Tsai, M.D., Ph.D. — Hualien Tzu Chi General Hospital
- Study coordinator: Sheng-Tzung Tsai, M.D., Ph.D.
- Email: flydream.tsai@gmail.com
- Phone: +886-3-856-1825
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.