Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Combined injury-site and lumbosacral epidural spinal cord stimulation to restore function after spinal cord injury

Official title: Combined Injury-site & Lumbosacral Epidural Stimulation for Spinal Cord Injury - a Pilot Study.

Run by The University of Hong Kong · NCT07139496 · Data updated 2026-11-12

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.

More Spinal Cord Injuries (SCI) trials

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment5 (estimated)
SponsorThe University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedSeptember 1, 2028
Study endsMarch 1, 2029
Registry record updatedDecember 1, 2025
Trial IDNCT07139496 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.