Clinical trial NCT05926843: Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury
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
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: motor restoration
chronic pain
rehabilitation
neuromodulation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant'Anna di Pisa
First posted: 2023-07-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Motor changes (MRC)
timeFrame: Before surgery, then monthly up to 6-month from surgery
measure: Motor changes (LEFS))
timeFrame: Before surgery, then monthly up to 6-month from surgery
Secondary outcomes:
measure: Spasticity changes
timeFrame: Before surgery, then monthly up to 6-month from surgery
measure: Longitudinal neurophysiological reorganization (electromyography)
timeFrame: Before surgery and 6 months after procedure
measure: Longitudinal neurophysiological reorganization (motor evoked potentials)
timeFrame: Before surgery and 6 months after procedure
measure: Longitudinal neurophysiological reorganization (sensory evoked potentials)
timeFrame: Before surgery and 6 months after procedure
measure: Longitudinal brain and spine MRI reorganization
timeFrame: Before surgery and 6 months after procedure
measure: Chronic pain changes (MPQ)
timeFrame: Before surgery and 6 months after procedure
measure: Chronic pain changes (PCS)
timeFrame: Before surgery and 6 months after procedure
measure: Chronic pain changes (ASC-12)
timeFrame: Before surgery and 6 months after procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
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.
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.
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.
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.
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.
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.