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| Name | Class |
|---|---|
| Beijing Tsinghua Changgeng Hospital | OTHER |
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The purpose of this experiment is to evaluate the efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients after Spinal Cord Injury
The whole course will last around 12 months, during which there will be: Pre-implant evaluations and standard rehabilitation (6-10 weeks), Stimulator implantation and stimulation optimization (4-8 weeks), Rehabilitation training with stimulation (6 months). At the end of the protocol, the study aims to make the patients walk better and faster.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | Participants will receive pre-implantation rehabilitation, implantation of the closed-loop spinal cord stimulator, and stimulation (according to the functional mapping) assisted rehabilitation post-implantation during the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pins Medical G122 RS | Device | G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space |
|
| Measure | Description | Time Frame |
|---|---|---|
| WISCI III | A Common method used to evaluate SCI patient's walking capability in clinical setting | Change from Baseline to the 8 month after implantation. |
| 10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking | 10-Meter Walk Test (10MWT) is commonly used to measure walking speeds during two conditions: a self-selected normal speed, and a self-selected 'faster-than-normal' speed. | Change from Baseline to the 8 month after implantation. |
| Weight Bearing Capacity | Weight-bearing capacity (WBC) is an important outcome to monitor and particularly relevant in patients with severe motor impairments who cannot walk independently. The investigators use LPG HUBER360 to examine subjects' weight bearing capacity | Change from Baseline to the 8 month after implantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Lu, MD | Contact | +8656119530 | yanglu@btch.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Luming Li, PhD | National Engineering Laboratory for Neuromodulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Engineering Laboratory for Neuromodulation | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42209714 | Derived | Li H, Wei Y, Sui Y, Zhang X, Luo X, Zhang B, Ma B. Predict neuromuscular performance in human epidural electrical stimulation: phase 1 trial interim results. Commun Med (Lond). 2026 May 29. doi: 10.1038/s43856-026-01695-3. Online ahead of print. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| D014947 | Wounds and Injuries |