Spinal Cord InjuriesNeuroSCSNCT05926843

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

A study testing Spinal cord stimulation surgery (device) and motor rehabilitation in people with Spinal Cord Injuries, run by IRCCS San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injuries
What is being tested?: Spinal cord stimulation surgery (device) 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: 19 Apr 2023to 1 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

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 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;

Show all 9Show fewer

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 (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;

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Ospedale San Raffaele
Milan, 20132

Other trials in Italy

About this study

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

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.

Conditions: Spinal Cord Injuries
Being tested: Spinal cord stimulation surgery (device) and motor rehabilitation
Keywords: motor restoration, chronic pain, rehabilitation, neuromodulation
Medical subject headings: Spinal Cord Injuries, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal cord stimulation surgery (device) 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 (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).

Study groups in NCT05926843
Study group	Role	What they receive
Individuals with functionally complete/incomplete spinal cord injury	Experimental	Individuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) who will undergo SCS for chronic pain Receives: Procedure: Spinal cord stimulation surgery (device) 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
Hand-held dynamometry
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.
Measured: From enrollment to the end of treatment at 6 months
IMU-based single-joint assessment
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.
Measured: From enrollment to the end of treatment at 6 months
Standing assessment
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.
Measured: From enrollment to the end of treatment at 6 months
Overground walking
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.
Measured: From enrollment to the end of treatment at 6 months

Secondary outcomes (9)

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
Functional and neuropsychological assessment
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.
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.

19 Apr 20231 Jul 2026

First posted3 Jul 2023
Study start19 Apr 2023
Primary completion30 Dec 2025
Study completion1 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05926843
Sponsor's protocol ID: Neuro-SCS-001
Acronym: NeuroSCS
Status last verified: Aug 2026
First submitted: 1 Jun 2023
Last updated: 26 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 23147846
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.
PubMed 29526043
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.
PubMed 34706778
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.
PubMed 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.
PubMed 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 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
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.
PubMed 40436013

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 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 After Spinal Cord Injury: an Interventional, Prospective, Monocentric Study
ClinicalTrials.gov ID: NCT05926843
Acronym / sponsor ID: NeuroSCS / Neuro-SCS-001
Conditions: Spinal Cord Injuries
Keywords: motor restoration, chronic pain, rehabilitation, neuromodulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: IRCCS San RaffaeleUniversity, hospital or other
Collaborators: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Study start: 19 Apr 2023 (actual)
Primary completion: 30 Dec 2025 (actual)
Study completion: 1 Jul 2026 (actual)
First posted: 3 Jul 2023 (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.

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 spinal cord injury	Experimental	Procedure: Spinal cord stimulation surgery (device) and motor rehabilitationIndividuals with functionally complete/incomplete spinal cord injury (ASIA grade A, B or C) 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 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;

Key exclusion criteria (6 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 (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;

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) 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 (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).	Procedure or surgery	Individuals with functionally complete/incomplete 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).
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.
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.
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.
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.

9 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
Functional and neuropsychological assessment
Time frame: Before surgery and 6 months after procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Results publication: PubMed 23147846Jackson 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.
Results publication: PubMed 29526043Sdrulla 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.
Results publication: PubMed 34706778Seanez 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.
Results publication: 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.
Results publication: 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.
Results publication: 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.
Derived from this study: 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.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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) and motor rehabilitation in people with Spinal Cord Injuries, run by IRCCS San Raffaele 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 6 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: finished, as of the sponsor's last update on 26 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 6 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 NCT05926843, which also lists 7 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 26 Aug 2026.