Spinal Cord DiseaseNeuro-scs-002NCT07412808
Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study
A study testing Spinal cord stimulation surgery (device implant) and motor rehabilitation in people with Spinal Cord Disease and Spinal Cord Injuries (Complete and Incomplete), run by Albano Luigi at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Disease, Spinal Cord Injuries (Complete and Incomplete)
- What is being tested?
- Spinal cord stimulation surgery (device implant) and motor rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffaele
Milan, 20132
Luigi Albano, MD, PhD, 0226435568 ext. +39, albano.luigi@hsr.it
Pietro Mortini, MD
About this 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
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.
- Being tested
- Spinal cord stimulation surgery (device implant) and motor rehabilitation
- Keywords
- motor restoration, rehabilitation, chronic pain, neuromodulation, spasticity
- Medical subject headings
- Spinal Cord Diseases, Spinal Cord Injuries, Chronic Pain, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation surgery (device implant) and motor rehabilitationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Spinal cord stimulation surgery (device implant) and motor rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Before surgery, then monthly up to 6-month from surgery
Secondary outcomes (8)
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).
Measured: Before surgery, then monthly up to 6-month from surgery
Longitudinal neurophysiological reorganization (electromyography)
Electromyography will be used to evaluate muscle response or electrical activity in response to a nerve's stimulation.
Measured: Before surgery and 6 months after procedure
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.
Measured: Before surgery and 6 months after procedure
Longitudinal neurophysiological reorganization (sensory evoked potentials)
Sensory evoked potentials will be used to assess electrical activity in the brain in response to sensory stimulation.
Measured: Before surgery and 6 months after procedure
Longitudinal brain and spine MRI reorganization
Structural and functional brain and spine MRI analysis.
Measured: Before surgery and 6 months after procedure
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.
Measured: Before surgery and 6 months after procedure
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.
Measured: Before surgery and 6 months after procedure
Chronic pain changes (ASC-12)
12-item Allodynia Symptom Checklist (ASC-12) evaluates presence of allodynia and hypoesthesia.
Measured: Before surgery and 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albano Luigi
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor-investigator, Albano Luigi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412808
- Sponsor's protocol ID
- Neuro-scs-002
- Acronym
- Neuro-scs-002
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Transl Med. 2025 Jan 8;17(780):eadp9607. doi: 10.1126/scitranslmed.adp9607. Epub 2025 Jan 8.
PubMed 39772775Albano 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.
PubMed 40436013Gill 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.
PubMed 30250140Angeli 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.
PubMed 30247091Wagner 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.
PubMed 30382197
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07412808
- Acronym / sponsor ID
- Neuro-scs-002 / Neuro-scs-002
- Keywords
- motor restoration, rehabilitation, chronic pain, neuromodulation, spasticity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Albano LuigiUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with functionally complete/incomplete non-traumatic spinal cord injury | Experimental | Procedure: Spinal cord stimulation surgery (device implant) and motor rehabilitationIndividuals with functionally complete/incomplete non-traumatic spinal cord injury who will undergo SCS for chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulation surgery (device implant) and motor rehabilitationThe 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). | Procedure or surgery | Individuals with functionally complete/incomplete non-traumatic spinal cord injury |
Primary outcome
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.
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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 39772775Romeni 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.
- Background: PubMed 40436013Albano 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.
- Background: PubMed 30250140Gill 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.
- Background: PubMed 30247091Angeli 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.
- Background: PubMed 30382197Wagner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation surgery (device implant) and motor rehabilitation in people with Spinal Cord Disease and Spinal Cord Injuries (Complete and Incomplete), run by Albano Luigi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor changes (MRC) (time frame: Before surgery, then monthly up to 6-month from surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07412808, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.