NCT07139496 Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation
| NCT ID | NCT07139496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-09-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. American Society of Anesthesiologist (ASA) status I-III 2. Age 18-70 years old 3. Patients with SCI more than 2 years 4. Traumatic or atraumatic spinal cord injury 5. American Spinal Injury Association (ASIA) Impairment Scale A and B 6. Have previous MRI to document extent of spinal cord injury before recruitment Exclusion Criteria: 1. Chronic opioid user 2. Presence of chronic pain condition (pain duration over 3 months) 3. Alcohol or substance abuse 4. active and unaddressed psychiatric diseases