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

San Donato Group (GSD)

Status

Enrolling

Conditions

Spinal Cord Injuries

Treatments

Procedure: Spinal cord stimulation surgery (device) and motor rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05926843

Neuro-SCS-001

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;