RecruitingNot ApplicableNCT06761404

Non-invasive VNS in Stroke Recovery

Sponsor

The Methodist Hospital Research Institute

Enrollment

60 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria8

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.

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Interventions

DEVICEtaVNS

Experimental. The current will be increased gradually for both sham and real stimulation at the beginning of the 90-minute stimulation to lessen the itchy/numb skin sensation and to create the same skin sensation for subject blinding.