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

NCT ID: NCT04969042

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2027-08-01

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pins Medical G122 RS

Intervention Type: DEVICE

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

Interventions

Pins Medical G122 RS

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Changgeng Hospital

OTHER

Sponsor Role: collaborator

Luming Li

OTHER

Sponsor Role: lead

Responsible Party

Luming Li

Director of National Engineering Laboratory for Neuromodulation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luming Li, PhD

Role: PRINCIPAL_INVESTIGATOR

National Engineering Laboratory for Neuromodulation

Locations

National Engineering Laboratory for Neuromodulation

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Lu, MD

Role: CONTACT

yanglu@btch.edu.cn

+8656119530

Facility Contacts

Yang Lu, MD

Role: primary

yanglu@btch.edu.cn

Other Identifiers

202000325

Identifier Type: -

Identifier Source: org_study_id