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

Phase 1RecruitingNCT04969042

Luming Li10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Pins Medical G122 RSDEVICE

G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

National Engineering Laboratory for Neuromodulation

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

WISCI III

A Common method used to evaluate SCI patient's walking capability in clinical setting

Time frame: 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.

Time frame: 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

Time frame: Change from Baseline to the 8 month after implantation.

Central Contacts

Yang Lu, MD

CONTACT

+8656119530 yanglu@btch.edu.cn

Data from ClinicalTrials.gov

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