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Non-invasive VNS in Stroke Recovery

Sponsored by The Methodist Hospital Research Institute

About this study

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

In this study, (Aim 1) we will test whether our non-invasive trans-auricular vagus nerve stimulation (taVNS) during occupational therapy task performance has the potential for large scale application through superior clinical benefit compared to sham in a broad group of stroke survivors including hemorrhagic strokes. To determine the predictors of effective brain rewiring in the individual stroke patient, we will use an EEG and/or functional MRI (fMRI) connectivity biomarker independently of the success of the stimulation paradigm (Aim 2). We will test the hypothesis that better motor function will be associated with increased motor network connectivity pattern. The central objective of this application is to determine whether taVNS significantly improves motor recovery for both ischemic…

Where this study is enrolling

Who can participate

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.

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.