Recruiting

VNS

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06761404

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

taVNS

Study Details

Brief summary:

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

Conditions

Stroke

Study ID

NCT06761404

Start date

Apr 15, 2025

Status verified date

Feb, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Stimulation

Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions..

experimental: taVNS

Weak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session.

Interventions

taVNS

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.

Primary outcome measure

  • To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery [ Time Frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)] ]

Central Contacts and Locations

Central contacts

Darrel W Cleere, MPH

7134413770dwcleere@houstonmethodist.org

Locations

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Darrel Cleere

713-441-3770dwcleere@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • taVNS
  • trans-auricular
  • non-invasive vagus nerve stimulation
  • stroke recovery
  • neuromodulation
  • rehabilitation
  • chronic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-03-02.