Non-invasive VNS in Stroke Recovery

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

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

Key facts

Study ID

NCT06761404

Run by

The Methodist Hospital Research Institute

People needed

60

Starts

2025-04-15

Expected to finish

2028-06-01

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Houston Methodist Research Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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