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

Spinal Cord Injuries Clinical Trial

— COFUN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969042
• Other study ID #: 202000325
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

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.