Spinal stimulation + rehab aims to restore walking in spinal cord injury
NCT ID NCT07412808
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining spinal cord stimulation with physical therapy can help people with non-traumatic spinal cord injury regain leg movement and the ability to stand or step. Ten adults who have had a spinal cord injury for at least one year and cannot walk independently will receive the treatment. The goal is to see if daily training with the stimulator on improves muscle strength and function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of NTSCI at least one year before presentation; 2. Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment; 3. Age ≥ 18 years; 4. Indication to spinal cord stimulation surgery for chronic pain; 5. Being unable to stand or step independently; 6. No current anti-spasticity medication regimen; 7. No botox injections in the prior 3 months; 8. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; 9. Willingness and ability to comply with scheduled visits and other trial procedures. Exclusion Criteria: 1. 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; 2. Pregnancy or breastfeeding; 3. Any significant psychiatric disease; 4. Use of illicit drugs; 5. Unstable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping; 6. Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training; 7. Spinal cord involvement above the D1 segment; 8. Severe peripheral neuropathies or damage to the cauda equine.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Ospedale San Raffaele
Milan, 20132, Italy
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Other studies related to the condition(s) this trial covers.
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