Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06761404

Non-invasive VNS in Stroke Recovery

Led by The Methodist Hospital Research Institute · Updated on 2026-03-02

60

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Non-invasive VNS in Stroke Recovery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Houston Methodist Research Institute

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Darrel W Cleere, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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