Using spinal cord stimulation and rehabilitation to improve movement after spinal cord injury
Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
NA · IRCCS San Raffaele · NCT05926843
This study is testing if combining spinal cord stimulation with movement training can help people with spinal cord injuries improve their ability to stand and walk on their own.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT05926843 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of spinal cord stimulation (SCS) combined with motor rehabilitation training in restoring motor function for patients with spinal cord injuries. Ten participants with varying degrees of spinal cord damage will receive SCS and engage in locomotor training aimed at improving their ability to stand and step independently. The study will assess the improvements in motor function resulting from this combined approach, which is based on recent findings suggesting that continuous stimulation during rehabilitation can enhance recovery. The research is conducted at IRCCS Ospedale San Raffaele in Milan, Italy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic spinal cord injuries who are unable to stand or step independently and are indicated for spinal cord stimulation surgery.
Not a fit: Patients with significant psychiatric diseases, those unable to undergo MRI, or those currently on anti-spasticity medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor function and independence for individuals with spinal cord injuries.
How similar studies have performed: Recent studies have shown promising results with similar approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of SCI from at least one-year post injury; * 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; * Be 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; * Willingness and ability to comply with scheduled visits and other trial procedures. 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 (i.e. metal clips, claustrophobia); * Pregnancy or breastfeeding; * Any significant psychiatric disease; * Use of illicit drugs; * 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;
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, motor restoration, chronic pain, rehabilitation, neuromodulation