Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury (COFUN)
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pins Medical G122 RS
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Stimulation, Closed-Loop
Eligibility Criteria
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
Sites / Locations
- National Engineering Laboratory for NeuromodulationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
WISCI III
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04969042
First Posted
July 6, 2021
Last Updated
July 11, 2021
Sponsor
Luming Li
Collaborators
Beijing Tsinghua Changgeng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04969042
Brief Title
Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
Acronym
COFUN
Official Title
Efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luming Li
Collaborators
Beijing Tsinghua Changgeng Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Stimulation, Closed-Loop
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pins Medical G122 RS
Intervention Description
G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space
Primary Outcome Measure Information:
Title
WISCI III
Description
A Common method used to evaluate SCI patient's walking capability in clinical setting
Time Frame
Change from Baseline to the 8 month after implantation.
Title
10-metre Walking Test 10-metre Walking Test 10-metre Walking Test 10 meter wlaking
Description
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.
Time Frame
Change from Baseline to the 8 month after implantation.
Title
Weight Bearing Capacity
Description
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
Time Frame
Change from Baseline to the 8 month after implantation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Lu, MD
Phone
+8656119530
Email
yanglu@btch.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luming Li, PhD
Organizational Affiliation
National Engineering Laboratory for Neuromodulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Engineering Laboratory for Neuromodulation
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Lu, MD
Email
yanglu@btch.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury
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