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Spinal implant plus rehab aims to help paralyzed patients stand and walk

NCT ID NCT05926843

Cure Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether a spinal cord stimulator, implanted surgically, combined with intensive motor rehabilitation can help people with spinal cord injury regain the ability to stand and step. Ten adults with complete or incomplete spinal cord injury who cannot currently stand or walk independently will receive the implant and then undergo daily locomotor training. The study measures changes in muscle strength, lower-limb function, standing ability, and walking speed and endurance to see if the combination therapy improves motor function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spinal cord stimulation surgery (implanted device) combined with motor rehabilitation training
What this could lead to
If successful, this approach could help people with spinal cord injury regain the ability to stand and walk, offering a path toward greater independence.
What could go wrong
This is a very small early-stage study (10 participants), so results may not apply broadly. The surgery carries risks, and the therapy may not restore full function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

10 people

The number who actually took part.

Started

Apr 2023

Finished

Jul 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

Chronic Pain spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

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