Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function After Spinal Cord Injury (NeuroSCS)

August 24, 2026 updated by: Albano Luigi, IRCCS San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individuals with functionally complete/incomplete spinal cord injury
Individuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) who will undergo SCS for chronic pain
Procedure: Spinal 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor changes (MRC)
Time Frame: 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.
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
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
Hand-held dynamometry
Time Frame: 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.
From enrollment to the end of treatment at 6 months
IMU-based single-joint assessment
Time Frame: 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.
From enrollment to the end of treatment at 6 months
Standing assessment
Time Frame: 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.
From enrollment to the end of treatment at 6 months
Overground walking
Time Frame: 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.
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity changes
Time Frame: 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).
Before surgery, then monthly up to 6-month from surgery
Longitudinal neurophysiological reorganization (electromyography)
Time Frame: 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.
Before surgery and 6 months after procedure
Longitudinal neurophysiological reorganization (motor evoked potentials)
Time Frame: 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.
Before surgery and 6 months after procedure
Longitudinal neurophysiological reorganization (sensory evoked potentials)
Time Frame: 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.
Before surgery and 6 months after procedure
Longitudinal brain and spine MRI reorganization
Time Frame: Before surgery and 6 months after procedure
Structural and functional brain and spine MRI analysis.
Before surgery and 6 months after procedure
Chronic pain changes (MPQ)
Time Frame: 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.
Before surgery and 6 months after procedure
Chronic pain changes (PCS)
Time Frame: 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.
Before surgery and 6 months after procedure
Chronic pain changes (ASC-12)
Time Frame: Before surgery and 6 months after procedure
12-item Allodynia Symptom Checklist (ASC-12) evaluates presence of allodynia and hypoesthesia.
Before surgery and 6 months after procedure
Functional and neuropsychological assessment
Time Frame: 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.
Before surgery and 6 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

July 1, 2026

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuro-SCS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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