Combined injury-site and lumbosacral epidural spinal cord stimulation to restore function after spinal cord injury
Combined Injury-site & Lumbosacral Epidural Stimulation for Spinal Cord Injury - a Pilot Study.
This project will try implanting a spinal cord stimulator at the injury site plus over the lower (lumbosacral) spine to see if it helps people with chronic complete spinal cord injury regain movement and improve function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07139496 on ClinicalTrials.gov |
What this trial studies
Participants will undergo surgical implantation of epidural stimulators at both the spinal cord injury site and the lumbosacral spinal cord, followed by a phased stimulation program paired with targeted physiotherapy. The first phase uses lumbosacral stimulation for three months combined with lower-limb muscle training focused on walking; later phases introduce or combine injury-site stimulation to target local circuits and autonomic pathways. Outcomes will include measures of motor activation, walking-related function, and autonomic changes, collected over serial follow-up visits. The protocol enrolls adults with chronic (>2 years) traumatic or atraumatic SCI who meet specific neurological and medical criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–70 with chronic spinal cord injury (>2 years), ASIA Impairment Scale A or B, acceptable operative risk (ASA I–III), and prior MRI documentation of the injury.
Not a fit: Patients who are chronic opioid users, have chronic pain lasting over three months, active substance abuse, or unaddressed psychiatric disorders are excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined stimulation approach could restore voluntary muscle activity, improve walking ability, and improve autonomic function for people with long-standing severe spinal cord injuries.
How similar studies have performed: Previous lumbosacral spinal cord stimulation studies have shown the ability to activate paralyzed muscles and improve function in chronic SCI, but combining injury-site and lumbosacral stimulation is a relatively novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Timmy CW Chan, MBBS
- Email: timmychancw@gmail.com
- Phone: (852)22555679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.