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

NCT04969042 | Recruiting Phase 1 DMC

• 1 other identifier: 202000325
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Stimulation; Closed-Loop

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

Stimulation

EXPERIMENTAL

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

Interventions

Pins Medical G122 RS DEVICE

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

Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luming Li: lead
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (1)

National Engineering Laboratory for Neuromodulation

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Luming Li, PhD

  National Engineering Laboratory for Neuromodulation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Lu, MD

CONTACT

+8656119530; yanglu@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of National Engineering Laboratory for Neuromodulation

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 20, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)