Spinal Cord Injuries
Conditions
Keywords
motor restoration, chronic pain, rehabilitation, neuromodulation
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.
Interventions
PROCEDURESpinal cord stimulation surgery (device) and motor rehabilitation
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).
Sponsors
IRCCS San Raffaele
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor changes (MRC) | 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)) | 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). |
| Hand-held dynamometry | From enrollment to the end of treatment at 6 months | Quantitative assessment of maximal voluntary isometric muscle force. Measurements were performed only in muscles reaching MRC grade ≥3, corresponding to active movement against gravity. The measured outcome was the maximal force generated during isometric contraction. |
| IMU-based single-joint assessment | From enrollment to the end of treatment at 6 months | Quantitative kinematic assessment of isolated lower-limb movements using wearable inertial measurement units (IMUs). The measured outcomes were the peak hip flexion angle and peak knee extension angle during stimulation-assisted single-joint movements. |
| Standing assessment | From enrollment to the end of treatment at 6 months | Functional evaluation of upright standing ability. Standing performance was quantified by: * duration of maintained standing (minutes); * percentage of body weight supported through the lower limbs, measured using a stabilometric platform. |
| Overground walking | From enrollment to the end of treatment at 6 months | 10-Meter Walking Test (10MWT). Standardized assessment of walking speed over a 10-meter distance. The measured outcome was the time required to complete the test, from which walking speed can be derived. In motor-incomplete participants the test was performed in the OFF condition whenever feasible, whereas motor-complete participants were assessed during active stimulation. Six-minute walk test (6MWT). Standardized assessment of walking endurance. The measured outcome was the total distance walked over six minutes. Motor-incomplete participants were assessed in the OFF condition whenever feasible, whereas motor-complete participants performed the test during active stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spasticity changes | Before surgery, then monthly up to 6-month from surgery | The Modified Ashworth scale will be used to evaluate spasticity. This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). |
| Longitudinal neurophysiological reorganization (electromyography) | Before surgery and 6 months after procedure | Electromyography will be used to evaluate muscle response or electrical activity in response to a nerve's stimulation. |
| Longitudinal neurophysiological reorganization (motor evoked potentials) | Before surgery and 6 months after procedure | 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. |
| Longitudinal neurophysiological reorganization (sensory evoked potentials) | Before surgery and 6 months after procedure | Sensory evoked potentials will be used to assess electrical activity in the brain in response to sensory stimulation. |
| Longitudinal brain and spine MRI reorganization | Before surgery and 6 months after procedure | Structural and functional brain and spine MRI analysis. |
| Chronic pain changes (MPQ) | Before surgery and 6 months after procedure | 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. |
| Chronic pain changes (PCS) | Before surgery and 6 months after procedure | 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. |
| Chronic pain changes (ASC-12) | Before surgery and 6 months after procedure | 12-item Allodynia Symptom Checklist (ASC-12) evaluates presence of allodynia and hypoesthesia. |
| Functional and neuropsychological assessment | Before surgery and 6 months after procedure | The WISCI II is used to assess functional status in patients with lower-limb disability; the SCIM to evaluate independence in activities of daily living; and the SF-36 to assess overall health-related quality of life. Mood and emotional status is assessed using the BDI for depressive symptoms and the STAI for anxiety. Apathy was assessed using the IDAS. |
Countries
Italy
Outcome results
None listed