Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Pins Medical G122 RS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation<br>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. | Device: Pins Medical G122 RS<br>* G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Stimulation, Closed-Loop