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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04969042
Other study ID # 202000325
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2021
Est. completion date August 1, 2027

Study information

Verified date July 2021
Source Tsinghua University
Contact Yang Lu, MD
Phone +8656119530
Email yanglu@btch.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 1, 2027
Est. primary completion date August 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China National Engineering Laboratory for Neuromodulation Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Luming Li Beijing Tsinghua Changgeng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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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