Closed-loop spinal cord stimulation for improving walking in spinal cord injury patients
Official title: Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
Run by Tsinghua University · NCT04969042 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Tsinghua University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 1, 2021 |
| Main results expected | August 1, 2026 |
| Study ends | August 1, 2027 |
| Registry record updated | July 20, 2021 |
| Trial ID | NCT04969042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe cognitive impairments, psychiatric disorders, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking capabilities in patients with spinal cord injuries.
How similar studies have gone: Other studies have shown promise with spinal cord stimulation techniques, but this specific closed-loop approach is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury
This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.
-
NG004 for incomplete cervical spinal cord injury
This trial tests NG004 versus placebo to see if it is safe and helps motor function and daily life in adults with acute incomplete cervical spinal cord injury.
-
Robot-assisted training for arm and leg movement after stroke or injury
This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.
-
ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab
This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.
-
Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury
This study tests whether using high-frequency sacral nerve stimulation together with bladder-directed ultrasound can reduce involuntary bladder contractions and improve bladder function in people with spinal cord injury.
-
Hybrid HIIT-FES cycling program for people with spinal cord injury
This study tests a hybrid exercise program that combines functional electrical stimulation cycling with voluntary arm work to improve health in adults with spinal cord injury.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.