Spinal stimulation trial hopes to restore movement and bladder control
NCT ID NCT04496609
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
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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 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jul 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 to 65 years
- 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.
Show the full entry requirements Hide 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.
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The places running it
2 sites. 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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Hôpital Foch
RECRUITINGSuresnes, 92150, France
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Hôpital Raymond Poincaré
RECRUITINGGarches, 92380, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?