Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07139496

Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation

Led by The University of Hong Kong · Updated on 2025-12-01

5

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Spinal cord stimulation (SCS) has been shown in previous studies to be capable of restoring motor and autonomic function in patients with chronic complete spinal cord injury (SCI). Clinical studies have demonstrated that SCS enables activation of previously paralyzed muscles, leading to functional improvements in patients in the chronic stage of paralysis through the delivery of activity-based interventions. For most previous studies on SCS in SCI, stimulation was invariably applied to lumbrosacral plexus only. In this study, after signing the consent form, the patient will be assigned for standard surgery with additional implant of the spinal cord stimulator. The investigators propose to conduct the SCS with three phases. For the first phase, SCS over lumbrosacral spinal cord will be activated for 3 months with appropriate stimulation of lower limb muscles for walking together with physiotherapy of individual muscle groups for walking. For the second phase, SCS over lumbrosacral spinal cord will be stopped. SCS over the injury site will be activated for 3 months with appropriate stimulation of lower limb muscles. For the third phase, SCS over both lumbrosacral spinal cord and injury site of spinal cord will be activated for another 3 months with appropriate stimulation of lower limb muscles.

CONDITIONS

Official Title

Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • American Society of Anesthesiologist (ASA) status I-III
  • Age between 18 and 70 years old
  • Patients with spinal cord injury for more than 2 years
  • Traumatic or atraumatic spinal cord injury
  • American Spinal Injury Association (ASIA) Impairment Scale A or B
  • Have previous MRI documenting extent of spinal cord injury before recruitment
Not Eligible

You will not qualify if you...

  • Chronic opioid user
  • Presence of chronic pain condition lasting over 3 months
  • Alcohol or substance abuse
  • Active and untreated psychiatric diseases

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Queen Mary Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

T

Timmy CW Chan, MBBS

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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