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Brain-Spine bridge aims to restore movement after stroke

NCT ID NCT07610850

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a device that reads brain signals and stimulates the spinal cord to help people with chronic stroke move their arms and legs again. Only 3 participants will be implanted with electrodes on the brain and spine. The main goal is to check safety, but researchers will also measure improvements in walking and limb function.

What this could mean

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

Active substance
ARC-BSI Stroke system (implanted brain and spinal cord stimulators)
What this could lead to
If it works, this could point toward a new way to restore voluntary movement in people with chronic stroke, potentially improving mobility and independence.
What could go wrong
This is a very early, tiny trial (only 3 participants) focused on safety. The surgery is invasive, and the approach may not work for everyone or may cause complications.

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 3 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2032

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 70 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: * Must be between 18-70 years old at the time of enrolment. * Must have suffered from a subcortical including brain stem stroke that occurred at least 9 months but not more than 10 years prior to enrolment. * Must have a score lower than 25 on the Fugl-Meyer upper-limb scale. * Must be able to stand with or without assistive device for 30 seconds. * Must have a score higher than 22 at the Montreal Cognitive Assessment. * Must present right or left hemiplegia. * Must have completed primary standard of care rehabilitation. * Must provide and sign the study's Informed Consent prior to any study-related procedures. * Must be able to understand and interact with the study team in French or English. * Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments. * Must use effective contraception for women of childbearing capacity. * Must be able to withhold antiplatelet/anticoagulation agents perioperatively for the time of the surgeries (if applicable). Exclusion Criteria: * Must not be pregnant or breast feeding (if applicable). * Must not have the intention to become pregnant during the study (if applicable). * Must not have any diseases and conditions that would increase the morbidity and mortality of the implantation surgery. * Must not have any mental instability, including a diagnosis of personality disorder, psychosis, substance abuse, or severe depression as assessed by the psychologist. * Must not have any other medical conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., major cognitive disorder, renal failure, hepatic dysfunction, epilepsy, etc.). * Must not have ongoing significant dysphagia or aspiration difficulties or require ventilator support. * Must not have any active implanted device, such as a pacemaker or other neurostimulator. * Must not have any spinal anatomical abnormalities or incompatibilities with the implanted system precluding surgery. * Must not have severe spasticity of the upper limb or lower limb (Modified Ashworth Scale \> 3). * Must not have indication requiring frequent MRIs. * Must not participate in another clinical study using drugs or medical devices that might interfere with the outcomes of the study. * Must not be the investigator him/herself, his/her family members, employees, and other dependent persons.

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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

    1 site. 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

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    RECRUITING

    Lausanne, Canton of Vaud, 1005, Switzerland

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