Actively Recruiting

Phase Not Applicable
Age: 16Years - 60Years
All Genders
NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-24

10

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are: Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES. Participants will: Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory function assessments using standardized protocols. Participate in structured rehabilitation training sessions while using the EES device. Report any adverse events and complete quality of life questionnaires at specified follow-up intervals.

CONDITIONS

Official Title

Epidural Electrical Stimulation in Spinal Cord Injury

Who Can Participate

Age: 16Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Spinal Cord Injury classified as ASIA B, C, or D
  • Injury level above the T10 vertebra
  • Injury duration between 8 and 36 months
  • WISCI II score less than 13
  • No significant motor improvement after rehabilitation in the past 2 months
  • Expected survival of 12 months or longer
  • Voluntary participation with signed consent and ability to comply with rehabilitation and follow-up
Not Eligible

You will not qualify if you...

  • Other severe organic neurological diseases or mental illnesses besides anxiety or depression
  • Bleeding or coagulation problems (prothrombin time 18 seconds or longer)
  • History of alcohol or drug abuse or dependence
  • Mental retardation, cognitive dysfunction, or personality disorders
  • History of electroconvulsive therapy or need for continuous electrotherapy
  • Implanted cardiac pacemaker, cardioverter, or defibrillator
  • Expected survival less than 1 year

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

J

Junming Zhu, Chief Physician

CONTACT

Z

Zhoule Zhu, Attending Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Epidural Electrical Stimulation in Spinal Cord Injury | DecenTrialz