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

NCT04969042 · tracked via the Priya Life Science China tracker

Sponsor

Luming Li

Phase

Phase 1

Started

2021-08-01

Last updated

2021-07-20

Condition(s) studied

Spinal Cord Injuries

Investigational drug(s) / intervention(s)

Pins Medical G122 RS

Pins Medical G122 RS: G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

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.
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

Trial sites (1)

Facility	City	Region	Status
National Engineering Laboratory for Neuromodulation	Beijing	Beijing Municipality	Recruiting

Other trials for the same condition

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling Recruiting

Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury Active, not recruiting

Combined Magnetic Stimulation and Ultrasound for Detrusor Overactivity in SCI Starting soon

Effect of Threshold Pressure-Loaded RMT + tTBS on Respiratory Function in SCI Patients Recruiting

Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04969042 on ClinicalTrials.gov ↗ ← All trials in China