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

Luming Li

Status and phase: Enrolling; Phase 1

Conditions: Spinal Cord Injuries

Treatments: Device: Pins Medical G122 RS

Study type: Interventional

Funder types: Other

Identifiers

NCT04969042

202000325

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stimulation

Experimental group

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.

Treatment:

Device: Pins Medical G122 RS