Restoring movement after chronic spinal cord injury with implanted epidural spinal stimulation and robotic rehabilitation

RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

This study will try implanting an epidural spinal stimulator and providing advanced robotic neurorehabilitation to adults with chronic motor-complete spinal cord injury to see if it improves neurological and motor function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: National Neuroscience Institute (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT05644171 on ClinicalTrials.gov

What this trial studies

Adults with chronic motor-complete spinal cord injury (AIS A or B, >1 year post-injury, C2–T12) will receive an implanted epidural spinal cord stimulator and participate in personalized activity-based robotic rehabilitation before and after surgery. The protocol expands a pilot program by recruiting 15 additional participants (in addition to 3 ongoing) and delivers perioperative and post-operative rehab sessions to monitor change. Study outcomes focus on neurological and functional improvements below the injury level, including voluntary movement and autonomic responses. Enrollment requires preserved segmental reflexes and the physical/psychological ability to complete an intensive rehabilitation program, with exclusions for major medical, orthopedic, or psychiatric contraindications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 or older with chronic (more than one year) motor-complete SCI (AIS A or B) between C2 and T12 who retain segmental reflexes and can undergo intensive perioperative rehabilitation.

Not a fit: Patients with significant medical comorbidities, unstable dysautonomia, untreated fractures or pressure sores, severe spasticity or osteoporosis, ongoing substance abuse or major psychiatric issues, pregnancy, or absent segmental reflexes are unlikely to benefit or will be excluded.

Why it matters

Potential benefit: If successful, the combined implant and rehabilitation approach could restore some voluntary movement and improve autonomic control and independence for people with chronic motor-complete SCI.

How similar studies have performed: Small studies and case series of epidural spinal stimulation plus activity-based training have shown promising gains in voluntary movement and stepping for some chronic SCI patients, but the approach remains experimental and not yet widely validated.

Eligibility criteria

⦁ Inclusion Criteria

For inclusion in the study, the potential patient has to fulfil all of the following criteria:

1. 21 years old and older
2. Chronic (greater than one year) motor complete (AIS classification A or B) SCI
3. Spinal injury between the levels of Cervical 2 (C2) to Thoracic 12 (T12)
4. Segmental reflexes that remain functional below the level of lesion
5. Able to perform the perioperative rehabilitation program as judged by the research team

   * Exclusion Criteria

Potential patients will be excluded from the trial if they fulfil any of the following criteria:

1. Significant medical co-morbidities that would significantly increase the risk of the operation
2. Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing
3. Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis
4. Significant psychological issues or ongoing drug abuse
5. Pregnancy and lactating patients
6. Progressive spinal cord disease

Where this trial is running

Singapore

• National Neuroscience Institute — Singapore, Singapore (Recruiting)

Study contacts

• Study coordinator: Kai Rui Wan, MBBS

Conditions Chronic Spinal Cord Injury; Spinal cord injury; Epidural spinal stimulation; Implantation