Brain-Spine bridge aims to restore movement after stroke
NCT ID NCT07610850
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
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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 3 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
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 70 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: * 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.
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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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Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITINGLausanne, Canton of Vaud, 1005, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Can a nurse and a neighbor help tame chronic disease?
- Can PET scans reveal hidden heart inflammation after a stroke?
- Two ways to catch a hidden heart rhythm after stroke