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Spinal stimulation trial hopes to restore movement and bladder control

NCT ID NCT04496609

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether electrical stimulation of the lower spinal cord, combined with rehabilitation, can help people with incomplete spinal cord injuries walk short distances and improve bladder and sexual function. Fourteen adults with stable, incomplete injuries will receive both stimulation plus rehab and rehab alone in a crossover design. The goal is to see if the stimulation provides added benefit over rehab alone.

What this could mean

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

Active substance
epidural electrical stimulation of the lumbosacral spinal cord
What this could lead to
If it works, this could point toward a way to help people with incomplete spinal cord injuries regain some movement and control over bladder and sexual functions.
What could go wrong
This is a very small early-stage trial with only 14 people, so results may not apply to everyone. The treatment is complex and may not work for all participants.

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

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jul 2029

An estimate. End dates often move.

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 to 65 years

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: * Aged between 18 and 65 years inclusive * Male or female * Incomplete ASIA B or C spinal cord lesion with level of lesion located above T10 (sensation preserved below level of lesion) * Absence of significant motor deficit of the upper limbs or recovered motor deficit (muscular score ≥ 4/5) * Patient with spinal cord injury at least 2 years old and considered stable not walking * Spinal cord lesion determined by spinal cord MRI (intramedullary hypersignal) * Patient who can benefit from an iterative rehabilitation programme * Patient with stable health condition with no cardiopulmonary disease * Patient with orthopaedic condition compatible with verticality and walking * Persistence of adductor reflexes up to L2 * Patient with no current neuromodulation implant: spinal cord neurostimulator, brain, peripheral nerve or intrathecal treatment * Patient with no coagulopathy, cardiac risk factors or other medical risk factors significant for surgery * Local anatomical conditions compatible with implantation of the epidural electrode (determined by MRI of the spinal cord) * Person who benefits from or is entitled to a social security scheme * Having provided signed informed consent Exclusion Criteria: * Significant cerebral lesion on a previous cerebral MRI * Psychiatric or cognitive disorder history (known or detected during the consultation with the psychologist) * Protected adult patients * Pregnant (determined by a negative pregnancy test) or breastfeeding women * Respiratory failure (vital capacity \< 50%) (surgery in prone position) * Repeated urinary infections (≥3 per year) * Planned absence that may hinder participation in the study (travelling abroad, relocation, imminent moving) * Patients with spasms (PENN scale \> 2) * Cauda equina syndrome * Patients presenting with a contraindication to an MRI being carried out: i) pacemaker, ii) non-MRI-compatible heart valve, iii) clips, stents, coils, etc. that are not MRI-compatible, iv) cochlear implant, v) metal foreign body, etc.) * Patients presenting with a contraindication to MEPs being carried out (notably wearing of ferromagnetic material, heart stimulator) * Patients on oral anticoagulants * Patients with botulinic toxin injection * Patients with bedsore * Undernourished patients (BMI \< 19)

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hôpital Foch

    RECRUITING

    Suresnes, 92150, France

  • Hôpital Raymond Poincaré

    RECRUITING

    Garches, 92380, France

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