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Tiny implant zaps nerves to boost stroke rehab
NCT ID NCT06716112
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a small implanted device that stimulates the vagus nerve could improve arm and hand function in people who had a stroke at least a year ago. Four participants received either real or sham stimulation paired with physical therapy. The goal was to see how the brain's pathways change, not to prove a treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vagus nerve stimulation (VNS) device
- What this could lead to
- If it works, this could point toward a way to improve motor recovery after stroke by pairing nerve stimulation with rehabilitation.
- What could go wrong
- This is a very small, early mechanistic study that was terminated early, so results may be limited and not generalizable. The device requires surgical implantation, which carries risks.
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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4 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Apr 2026
- 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.
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: * Ability to provide signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * 22-79 years of age * Unilateral supratentorial ischemic stroke that occurred ≥ 12 months prior to enrollment * Upper extremity Fugl-Meyer Assessment score of 20 to 50 * Modified Rankin Score of 2, 3, or 4 * Meets all clinical criteria for VNS implantation as determined by the PI and clinical care team Exclusion Criteria: * Intracerebral hemorrhage or traumatic brain injury * Deficits in language or attention that interfere with study participation * Severe spasticity (Modified Ashworth \> 3) * Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation * 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 * Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use, the following medically acceptable birth control methods:\* (1) sterilization surgery for women, (2) Surgical Sterilization Implant for Women, (3) sterilization surgery for men, (4) long-acting reversible contraceptives (LARC) - implantable rod and IUD; (5) contraceptive shot/injection every 3 months; (6) oral contraceptives ("The Pill"); (7) contraceptive patch; and (8) vaginal contraceptive ring. * Concurrent participation in another interventional clinical trial * Ferromagnetic metal in head (except dental work) or torso * Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability\*; or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation: may pose a significant or undue risk to the person; make it unlikely the person will complete all the study requirements per protocol; or may adversely impact the integrity of the data or the validity of the study results. \[\*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal, peripheral vascular, cardiac, endocrinologic (e.g., diabetes), immunologic, psychiatric (e.g., substance use), neurologic (e.g., cognitive), or dysphagia\] * Persons with a neck circumference larger than 18.5 inches * As determined by the principal investigator, is under current incarceration or legal detention
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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.
Contacts and locations
Locations
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NYU Langone Health
New York, New York, 10016, United States
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The University of Texas at Dallas
Richardson, Texas, 75080, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A wearable ankle robot may boost walking recovery after stroke
- Virtual reality rehab aims to bring stroke therapy home
- Which balance training works better after stroke? a trial puts two methods to the test
- Could a cuff and a tingle restore leg strength after stroke?
- Can gentle electrical pulses reawaken hand movement after stroke?
- Can foot sensation predict balance problems in stroke survivors?