Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury

Launched by IRCCS SAN RAFFAELE · Jun 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of spinal cord stimulation (SCS) combined with motor rehabilitation training to help improve movement in people who have suffered spinal cord injuries. The research will enroll ten participants, aged 18 and older, who have been diagnosed with spinal cord injuries for at least a year and experience difficulty standing or walking. Participants must also be recommended for SCS surgery due to chronic pain and must not be taking certain medications that could interfere with the study.

During the trial, participants will receive spinal cord stimulation alongside daily locomotor training, which aims to help them regain the ability to stand and step independently. The goal is to see if this combined approach can significantly improve their motor function. If you or someone you know is interested in participating, it's essential to consider the eligibility criteria and be prepared to attend scheduled visits throughout the study.

Gender

ALL

Eligibility 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;