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

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

Recruiting
18-70 years
All
Phase 1

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Overview

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

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.

Eligibility

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 details
    Spinal Cord Injuries

NCT04969042

Luming Li

28 January 2024

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