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

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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Pins Medical G122 RS

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yang Lu, MD; Phone Number: +8656119530; Email: yanglu@btch.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • National Engineering Laboratory for Neuromodulation
      • Contact: Yang Lu, MD; Email: yanglu@btch.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Luming Li
• Collaborators: Beijing Tsinghua Changgeng Hospital
• Investigators: Principal Investigator: Luming Li, PhD, National Engineering Laboratory for Neuromodulation

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2026
• Study Completion (Anticipated): August 1, 2027

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation; Closed-Loop
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 202000325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No