New wireless device boosts stroke recovery by zapping nerves during rehab
NCT ID NCT04534556
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a wireless device that stimulates the vagus nerve during rehabilitation exercises to help people who have had a stroke recover arm and hand function. The approach, called targeted plasticity therapy, aims to enhance the brain's ability to rewire itself. The trial includes 42 adults with chronic stroke and focuses on safety and feasibility.
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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 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Jan 2027
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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22 to 79 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Adult, aged 22-79 * Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment * UEFM score of 20 to 50 * Modified Rankin Score of 2, 3, or 4 * Right vocal cord has normal movement when assessed by laryngoscopy * Women of reproductive potential must use contraceptive protection * Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Deficits in language or attention that interfere with study participation * Severe spasticity (Modified Ashworth ≥ 3) * Medical or mental instability that would likely interfere with study protocol * Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.) * Presence of any other implanted electrical stimulation device * Prior injury to vagus nerve * Lactating, pregnant, or plan to become pregnant * Participation in another interventional clinical trial * Clinical complications that hinder or contraindicate the surgical procedure * Abusive use of alcohol and/or illegal substances use * Participants with sickle cell, lupus, clotting disorders or active neoplastic disease. * Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator. * Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance. * Recent history of syncope * Recent history of dysphagia * Current or anticipated requirement for diathermy * Uncontrolled hypertension * Diagnosed with Cerebral amyloid angiopathy
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Robot could let stroke patients rehab their hands at home without a therapist
- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next