Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interven… (NCT07412808) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study
Italy10 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of NTSCI at least one year before presentation;
✓. Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment;
✓. Age ≥ 18 years;
✓. Indication to spinal cord stimulation surgery for chronic pain;
✓. Being unable to stand or step independently;
✓. No current anti-spasticity medication regimen;
✓. No botox injections in the prior 3 months;
✓. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Motor changes (MRC)
Timeframe: Before surgery, then monthly up to 6-month from surgery
2
Motor changes (LEFS)
Timeframe: Before surgery, then monthly up to 6-month from surgery
✕. Unstable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping;
✕. Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;
✕. Spinal cord involvement above the D1 segment;
✕. Severe peripheral neuropathies or damage to the cauda equine.