Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Motor changes (MRC)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Albano Luigi
MD, PhD, Assistant Professor of Neurosurgery
IRCCS San Raffaele
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;
Outcomes
Primary Outcomes
Motor changes (MRC)
Time Frame: Before surgery, then monthly up to 6-month from surgery
The Medical Research Council's (MRC) scale of muscle power will be used to evaluate motor weakness. The MRC scale of muscle strength uses a score from Grade 5 (normal) to Grade 0 (no visible contraction) to assess the power of a particular muscle group in relation to the movement of a single joint.
Motor changes (LEFS))
Time Frame: Before surgery, then monthly up to 6-month from surgery
The Lower Extremity Functional Scale (LEFS) will be used by clinicians as a measure of lower extremity function. It is a questionnaire containing 20 questions about a person's ability to perform everyday tasks (minimum score 0, maximum score 80).
Secondary Outcomes
- Chronic pain changes (MPQ)(Before surgery and 6 months after procedure)
- Chronic pain changes (PCS)(Before surgery and 6 months after procedure)
- Longitudinal brain and spine MRI reorganization(Before surgery and 6 months after procedure)
- Spasticity changes(Before surgery, then monthly up to 6-month from surgery)
- Longitudinal neurophysiological reorganization (motor evoked potentials)(Before surgery and 6 months after procedure)
- Longitudinal neurophysiological reorganization (sensory evoked potentials)(Before surgery and 6 months after procedure)
- Longitudinal neurophysiological reorganization (electromyography)(Before surgery and 6 months after procedure)
- Chronic pain changes (ASC-12)(Before surgery and 6 months after procedure)