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

Phase 1

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Device: Pins Medical G122 RS

• Registration Number: NCT04969042
• Lead Sponsor: Luming Li

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20
• Study Start: 2021-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation	Pins Medical G122 RS	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.

Primary Outcome Measures

Name	Time	Method
Weight Bearing Capacity	Change from Baseline to the 8 month after implantation.	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
WISCI III	Change from Baseline to the 8 month after implantation.	A Common method used to evaluate SCI patient's walking capability in clinical setting
10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking	Change from Baseline to the 8 month after implantation.	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.

Trial Locations

Locations (1)

National Engineering Laboratory for Neuromodulation; 🇨🇳 Beijing, Beijing, China