Back to resultsSpinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury (NeuroSCS)
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Spinal cord stimulation surgery (device) and motor rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring motor restoration, chronic pain, rehabilitation, neuromodulation
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;
Sites / Locations
- IRCCS Ospedale San RaffaeleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individuals with functionally complete/incomplete spinal cord injury
Arm Description
Individuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) who will undergo SCS for chronic pain
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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).
Longitudinal neurophysiological reorganization (electromyography)
Electromyography will be used to evaluate muscle response or electrical activity in response to a nerve's stimulation.
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.
Longitudinal neurophysiological reorganization (sensory evoked potentials)
Sensory evoked potentials will be used to assess electrical activity in the brain in response to sensory stimulation.
Longitudinal brain and spine MRI reorganization
Structural and functional brain and spine MRI analysis.
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.
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.
Chronic pain changes (ASC-12)
12-item Allodynia Symptom Checklist (ASC-12) evaluates presence of allodynia and hypoesthesia.
Full Information
NCT ID
NCT05926843
First Posted
June 1, 2023
Last Updated
June 23, 2023
Sponsor
IRCCS San Raffaele
Collaborators
Scuola Superiore Sant'Anna di Pisa
1. Study Identification
Unique Protocol Identification Number
NCT05926843
Brief Title
Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury
Acronym
NeuroSCS
Official Title
Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
Collaborators
Scuola Superiore Sant'Anna di Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
motor restoration, chronic pain, rehabilitation, neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individuals with functionally complete/incomplete spinal cord injury
Arm Type
Experimental
Arm Description
Individuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) who will undergo SCS for chronic pain
Intervention Type
Procedure
Intervention Name(s)
Spinal cord stimulation surgery (device) and motor rehabilitation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Motor changes (MRC)
Description
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.
Time Frame
Before surgery, then monthly up to 6-month from surgery
Title
Motor changes (LEFS))
Description
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).
Time Frame
Before surgery, then monthly up to 6-month from surgery
Secondary Outcome Measure Information:
Title
Spasticity changes
Description
The Modified Ashworth scale will be used to evaluate spasticity. This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity).
Time Frame
Before surgery, then monthly up to 6-month from surgery
Title
Longitudinal neurophysiological reorganization (electromyography)
Description
Electromyography will be used to evaluate muscle response or electrical activity in response to a nerve's stimulation.
Time Frame
Before surgery and 6 months after procedure
Title
Longitudinal neurophysiological reorganization (motor evoked potentials)
Description
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.
Time Frame
Before surgery and 6 months after procedure
Title
Longitudinal neurophysiological reorganization (sensory evoked potentials)
Description
Sensory evoked potentials will be used to assess electrical activity in the brain in response to sensory stimulation.
Time Frame
Before surgery and 6 months after procedure
Title
Longitudinal brain and spine MRI reorganization
Description
Structural and functional brain and spine MRI analysis.
Time Frame
Before surgery and 6 months after procedure
Title
Chronic pain changes (MPQ)
Description
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.
Time Frame
Before surgery and 6 months after procedure
Title
Chronic pain changes (PCS)
Description
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.
Time Frame
Before surgery and 6 months after procedure
Title
Chronic pain changes (ASC-12)
Description
12-item Allodynia Symptom Checklist (ASC-12) evaluates presence of allodynia and hypoesthesia.
Time Frame
Before surgery and 6 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Albano, MD, PhD
Phone
0226432396
Ext
+39
Email
albano.luigi@hsr.it
First Name & Middle Initial & Last Name & Degree
Pietro Mortini, MD
First Name & Middle Initial & Last Name & Degree
Luigi Albano, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23147846
Citation
Jackson A, Zimmermann JB. Neural interfaces for the brain and spinal cord--restoring motor function. Nat Rev Neurol. 2012 Dec;8(12):690-9. doi: 10.1038/nrneurol.2012.219. Epub 2012 Nov 13.
Results Reference
result
PubMed Identifier
29526043
Citation
Sdrulla AD, Guan Y, Raja SN. Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms. Pain Pract. 2018 Nov;18(8):1048-1067. doi: 10.1111/papr.12692. Epub 2018 Apr 23.
Results Reference
result
PubMed Identifier
34706778
Citation
Seanez I, Capogrosso M. Motor improvements enabled by spinal cord stimulation combined with physical training after spinal cord injury: review of experimental evidence in animals and humans. Bioelectron Med. 2021 Oct 28;7(1):16. doi: 10.1186/s42234-021-00077-5.
Results Reference
result
PubMed Identifier
30250140
Citation
Gill ML, Grahn PJ, Calvert JS, Linde MB, Lavrov IA, Strommen JA, Beck LA, Sayenko DG, Van Straaten MG, Drubach DI, Veith DD, Thoreson AR, Lopez C, Gerasimenko YP, Edgerton VR, Lee KH, Zhao KD. Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia. Nat Med. 2018 Nov;24(11):1677-1682. doi: 10.1038/s41591-018-0175-7. Epub 2018 Sep 24. Erratum In: Nat Med. 2018 Oct 23;:
Results Reference
result
PubMed Identifier
30247091
Citation
Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24.
Results Reference
result
PubMed Identifier
30382197
Citation
Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
Results Reference
result
Learn more about this trial
Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury
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