Closed-loop spinal cord stimulation for improving walking in spinal cord injury patients
Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
This study is testing if a new type of spinal cord stimulation can help people with spinal cord injuries walk better during their rehab.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tsinghua University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04969042 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Closed-loop Functional Spinal Cord Stimulation in enhancing walking rehabilitation for patients with spinal cord injuries. The study spans approximately 12 months, including pre-implant evaluations, stimulator implantation, and rehabilitation training with stimulation. Participants will undergo a structured rehabilitation program aimed at improving their walking ability and speed. The trial involves a combination of medical interventions and physical therapy to optimize patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with spinal cord injuries classified as AIS A, B, C, or D and lesions at T10 or above.
Not a fit: Patients with severe cognitive impairments, psychiatric disorders, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking capabilities in patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise with spinal cord stimulation techniques, but this specific closed-loop approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18\~70 * Spinal cord injury staging(AIS) A,B,C or D * Level of lesion is T10 and above * Distance between lesion and conus \>60mm * Injured Time \> 3 months * Capable of participating rehabilitation program * Agree to comply with all conditions of the study and to attend all required study training and visits Exclusion Criteria: * With Obvious psychiatric disorder that cannot complete relevant questionaires * Cognitive impairment * Severe autonomic reflex disorder * Severe muscle atrophy and joint contracture * Cannot participate in spinal cord stimulation surgery or follow-up visits * Life expectancy less than 12 months * Abnormal blood or other physiological examinations that cannot conduct surgery, such as blood coagulation disorder or kidney/liver abnormalities * Uncontrollable hypertension, heart diseases, respiratory diseases or took related medicine in last 3 months * Unsuitable candidates in PI's perspective
Where this trial is running
Beijing, Beijing Municipality
- National Engineering Laboratory for Neuromodulation — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Luming Li, PhD — National Engineering Laboratory for Neuromodulation
- Study coordinator: Yang Lu, MD
- Email: yanglu@btch.edu.cn
- Phone: +8656119530
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.