Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury: an Interventional, Prospective, Monocentric Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 10
Treatments
Experimental: Individuals with functionally complete/incomplete spinal cord injury
Individuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) who will undergo SCS for chronic pain
Related Therapeutic Areas
Sponsors
Collaborators: Scuola Superiore Sant'Anna di Pisa
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov