Non-invasive VNS in Stroke Recovery

This study is looking at whether a non-invasive device called trans-auricular vagus nerve stimulation (taVNS) can help people recover better after a stroke. taVNS delivers a gentle electrical current to a nerve in your ear. Researchers want to see if using taVNS during occupational therapy (a type of rehabilitation) helps improve movement more than therapy alone. They will also look at brain activity to understand how taVNS might work. You could join if you are over 18, had an ischemic or hemorrhagic stroke more than six months ago, and have some weakness on one side of your body. The study aims to see if taVNS can lead to lasting improvements in hand movement.

Study design: This interventional study plans to enroll 60 participants. It compares taVNS with a sham (inactive) stimulation.
What's involved: You would receive 90-minute stimulation sessions, and your recovery will be measured at baseline, 6 weeks, 12 weeks, and for some, at 18 weeks.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for up to 12 weeks after the intervention, with some in the sham group followed for 18 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Non-invasive VNS in Stroke Recovery

Recruiting

NAAges 18+InterventionalTreatment

The Methodist Hospital Research Institute

~60 participants

Updated 2026-03-02 on ClinicalTrials.gov

What's tested:taVNS

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery

Measured over [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]

Conditions

Stroke

NCT06761404

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Houston Methodist Research Institute
Houston, Texasstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Timea Hodics, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Darrel W Cleere, MPH

[email protected]

7134413770

Email the study team

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Eligibility criteria

Inclusion

Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).

Age more than 18, Male or Female, All racial and ethnic groups

Entry into the study \>6 months post onset

Patients who can safely undergo taVNS

Able to follow 2 step commands

Modified Ashworth Scale Score =\<3 in the involved upper extremity

Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand

UFM =\< 60 (scale 0-66)

Exclusion

Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).

Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)

Subjects with contraindication to MRI of the brain

Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).

Patients with unstable cardiac arrhythmia, reentry tachycardia.

Pregnancy

Patients with pacemakers or stimulators that interfere with the stimulation, or other investigational devices or drugs

Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However we plan to include them once funding has been secured in the subsequent larger trial.

What this trial measures

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery[Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population Upper extremity Fugl-Meyer (uFM) The uFM test measures both proximal and distal upper extremity movements, ranges 0-66, higher score is better.

Trialytics