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

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

⦁ 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 it's running

• National Neuroscience Institute
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Kai Rui Wan, MBBS
• Email: wan.kai.rui@singhealth.com
• Phone: 63577538

Similar studies

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

• NVG-291 in adults with chronic cervical spinal cord injury

  This study tests whether NVG-291 can help improve hand function and daily activities in adults with chronic cervical motor-incomplete spinal cord injury, compared to a placebo.

  Recruiting at 4 sites Phase 3 NervGen Pharma · Birmingham, Alabama and 22 other locations · NCT07799532

• ARC-IM therapy to help restore walking after spinal cord injury

  This study will try ARC-IM Therapy (epidural electrical stimulation) in adults with subacute or chronic traumatic spinal cord injury to see if it helps improve walking and other ambulatory functions.

  Recruiting Ecole Polytechnique Fédérale de Lausanne · Nottwil, Canton of Lucerne and 1 other locations · NCT07234903

• First-in-human STUP-001 gene therapy to convert spinal cord support cells into neurons for chronic spinal cord injury

  This trial will test STUP-001, an AAV gene therapy that aims to convert astrocytes into neurons, in adults 19–60 with chronic AIS-A or AIS-B spinal cord injuries to see if it is safe and shows early signs of helping function.

  Recruiting Phase 1/2 Yonsei University · Seoul · NCT06922890

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.