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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Procedure: Spinal cord stimulation surgery (device) and motor rehabilitation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individuals with functionally complete/incomplete spinal cord injury<br>Individuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) who will undergo SCS for chronic pain | Procedure: Spinal cord stimulation surgery (device) and motor rehabilitation<br>* The first part of the study will involve a preoperative evaluation. Participants' clinical history, neurological, neurophysiological and advanced brain/spine MRI examination will be assessed (Part 1). Subsequently, participants will undergo spinal cord stimulation surgery which involves the implantation of a medical device (Part 2). After the surgery, the research participants will be hospitalized at the Neurosurgery Unit (10 days) to monitor the incision site (Part 3). Thereafter, the patients will be moved (for at least 6 weeks) to the Rehabilitation Unit in order to identify appropriate stimulation parameters for inducing stepping and standing and for starting training. The combination of epidural stimulation with manual step/stand training will be thus evaluated (Part 4). Patients will be finally assessed by clinical evaluation, advanced MRI and neurophysiological examination to study the brain, spine and peripheral functions after six months (Part 5).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor changes (MRC) | 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. | Before surgery, then monthly up to 6-month from surgery | 
| Motor changes (LEFS)) | 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). | Before surgery, then monthly up to 6-month from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity changes | The Modified Ashworth scale will be used to evaluate spasticity. This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). | Before surgery, then monthly up to 6-month from surgery | 
| Longitudinal neurophysiological reorganization (electromyography) | Electromyography will be used to evaluate muscle response or electrical activity in response to a nerve's stimulation. | Before surgery and 6 months after procedure | 
| Longitudinal neurophysiological reorganization (motor evoked potentials) | Motor evoked potentials will be used to evaluate electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain. | Before surgery and 6 months after procedure | 
| Longitudinal neurophysiological reorganization (sensory evoked potentials) | Sensory evoked potentials will be used to assess electrical activity in the brain in response to sensory stimulation. | Before surgery and 6 months after procedure | 
| Longitudinal brain and spine MRI reorganization | Structural and functional brain and spine MRI analysis. | Before surgery and 6 months after procedure | 
| Chronic pain changes (MPQ) | The McGill Pain Questionnaire (MPQ) can be used to evaluate a person experiencing significant pain. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. | Before surgery and 6 months after procedure | 
| Chronic pain changes (PCS) | The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking. It assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing. | Before surgery and 6 months after procedure | 
| Chronic pain changes (ASC-12) | 12-item Allodynia Symptom Checklist (ASC-12) evaluates presence of allodynia and hypoesthesia. | Before surgery and 6 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor restoration, chronic pain, rehabilitation, neuromodulation