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

NCT07412808 | Not Yet Recruiting DMC

• 1 other identifier: Neuro-scs-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Spinal Cord Disease; Spinal Cord Injuries (Complete and Incomplete)

Keywords

motor restoration; rehabilitation; chronic pain; neuromodulation; spasticity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Spasticity changes

  Before surgery, then monthly up to 6-month from surgery

• Longitudinal neurophysiological reorganization (electromyography)

  Before surgery and 6 months after procedure

• Longitudinal neurophysiological reorganization (motor evoked potentials)

  Before surgery and 6 months after procedure

• Longitudinal neurophysiological reorganization (sensory evoked potentials)

  Before surgery and 6 months after procedure

• Longitudinal brain and spine MRI reorganization

  Before surgery and 6 months after procedure

Study Arms (1)

Individuals with functionally complete/incomplete non-traumatic spinal cord injury

EXPERIMENTAL

Individuals with functionally complete/incomplete non-traumatic spinal cord injury who will undergo SCS for chronic pain

Procedure: Spinal cord stimulation surgery (device implant) and motor rehabilitation

Interventions

Spinal cord stimulation surgery (device implant) and motor rehabilitation PROCEDURE

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 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).

Individuals with functionally complete/incomplete non-traumatic spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scuola Superiore Sant'Anna di Pisa: collaborator
• Albano Luigi: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (5)

• 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 Transl Med. 2025 Jan 8;17(780):eadp9607. doi: 10.1126/scitranslmed.adp9607. Epub 2025 Jan 8.

  PMID: 39772775 BACKGROUND

• 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 spinal cord injury involving the conus medullaris: A case study. Med. 2025 Oct 10;6(10):100706. doi: 10.1016/j.medj.2025.100706. Epub 2025 May 27.

  PMID: 40436013 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30382197 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Diseases; Spinal Cord Injuries; Chronic Pain; Muscle Spasticity

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

IT (1)