Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study

Official title

Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function in Non-traumatic Spinal Cord Injury: an Interventional, Prospective, Monocentric Study

Overview

Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with non-traumatic 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

• Procedure Spinal cord stimulation surgery (device implant) 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 (5-14 days) to monitor the incision site (Part 3). Thereafter, the patient

Primary outcome measures

• Motor changes (MRC) [Time frame: Before surgery, then monthly up to 6-month from surgery]
• Motor changes (LEFS) [Time frame: Before surgery, then monthly up to 6-month from surgery]

Secondary outcome measures (8)

• Spasticity changes [Time frame: Before surgery, then monthly up to 6-month from surgery]
• Longitudinal neurophysiological reorganization (electromyography) [Time frame: Before surgery and 6 months after procedure]
• Longitudinal neurophysiological reorganization (motor evoked potentials) [Time frame: Before surgery and 6 months after procedure]
• Longitudinal neurophysiological reorganization (sensory evoked potentials) [Time frame: Before surgery and 6 months after procedure]
• Longitudinal brain and spine MRI reorganization [Time frame: Before surgery and 6 months after procedure]
• Chronic pain changes (MPQ) [Time frame: Before surgery and 6 months after procedure]
• Chronic pain changes (PCS) [Time frame: Before surgery and 6 months after procedure]
• Chronic pain changes (ASC-12) [Time frame: Before surgery and 6 months after procedure]

Eligibility criteria

Inclusion criteria

• Diagnosis of NTSCI at least one year before presentation;
• 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;
• Being 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;
• 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;
• Spinal cord involvement above the D1 segment;
• Severe peripheral neuropathies or damage to the cauda equine.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Ospedale San Raffaele — Milan

Publications

• Romeni S, Losanno E, Emedoli D, Albano L, Agnesi F, Mandelli C, Barzaghi LR, Pompeo E, Mura C, Alemanno F, Tettamanti A, Castellazzi P, Ciucci C, Fossati V, Toni L, Caravati H, Bandini A, Del Carro U, Agosta F, Filippi M, Iannaccone S, Mortini P, Micera S. High-frequency epidural electrical stimulation reduces spasticity and facilitates walking recovery in patients with spinal cord injury. Sci Tra PMID 39772775
• Albano L, Emedoli D, Agnesi F, Romeni S, Losanno E, Toni L, Fossati V, Ciucci C, Gasperotti F, Cociani L, Zucco G, Pompeo E, Mura C, Carpaneto J, Tettamanti A, Castelnovo V, Padul JD, Mandelli C, Barzaghi LR, Alemanno F, Caravati H, Butera C, Del Carro U, Castellano A, Falini A, Agosta F, Filippi M, Iannaccone S, Mortini P, Micera S. Epidural electrical stimulation facilitates motor recovery in sp PMID 40436013
• 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. PMID 30250140
• 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. PMID 30247091
• 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 PMID 30382197

Identifiers

NCT: NCT07412808 · Neuro-scs-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗