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

Sponsor

Luming Li (Other)

Overall Status

Recruiting

CT.gov ID

NCT04969042

Collaborator

Beijing Tsinghua Changgeng Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Device: Pins Medical G122 RS	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stimulation 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.	Device: Pins Medical G122 RS G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space

Arm

Intervention/Treatment

Experimental: Stimulation

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.

Device: Pins Medical G122 RS

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Engineering Laboratory for Neuromodulation	Beijing	Beijing	China

Sponsors and Collaborators

Luming Li
Beijing Tsinghua Changgeng Hospital

Investigators

Principal Investigator: Luming Li, PhD, National Engineering Laboratory for Neuromodulation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luming Li, Director of National Engineering Laboratory for Neuromodulation, Tsinghua University

ClinicalTrials.gov Identifier:

NCT04969042

Other Study ID Numbers:

202000325

First Posted:

Jul 20, 2021

Last Update Posted:

Jul 20, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Luming Li, Director of National Engineering Laboratory for Neuromodulation, Tsinghua University

Spinal Cord Stimulation

Closed-Loop

Additional relevant MeSH terms:

Spinal Cord Injuries

Wounds and Injuries

Study Results

No Results Posted as of Jul 20, 2021