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Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation
Sponsor: The University of Hong Kong
Summary
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.
Official title: Combined Injury-site & Lumbosacral Epidural Stimulation for Spinal Cord Injury - a Pilot Study.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2025-09-01
Completion Date
2029-03-01
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
Spinal Cord Stimulator
After the implantation of the spinal cord stimulator, the study will begin with 3 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. 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 walking. 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 for walking During all the phrases, physiotherapy of individual muscle groups for walking will be arranged. Exoskeleton training will also be arranged for 4 to 5 hours per week.
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong