Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study
Not yet recruitingNot applicableNCT07412808
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with non-traumatic spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete/complete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.
Study details
- Official title
- Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function in Non-traumatic Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
- Conditions
- Spinal Cord Disease
- Spinal Cord Injuries (Complete and Incomplete)
- Interventions
- Procedure: Spinal cord stimulation surgery (device implant) and motor rehabilitation
- Sponsor
- Albano Luigi
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Organization
- IRCCS San Raffaele
- Start date
- 2026-03
- Primary completion
- 2028-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Diagnosis of NTSCI at least one year before presentation; 2. Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment; 3. Age ≥ 18 years; 4. Indication to spinal cord stimulation surgery for chronic pain; 5. Being unable to stand or step independently; 6. No current anti-spasticity medication regimen; 7. No botox injections in the prior 3 months; 8. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; 9. Willingness and ability to comply with scheduled visits and other trial procedures. Exclusion Criteria: 1. Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated; 2. Pregnancy or breastfeeding; 3. Any significant psychiatric disease; 4. Use of illicit drugs; 5. Unstable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping; 6. Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training; 7. Spinal cord involvement above the D1 segment; 8. Severe peripheral neuropathies or damage to the cauda equine.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07412808