Non-invasive vagus nerve stimulation for stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and effectiveness of non-invasive trans-auricular vagus nerve stimulation (taVNS) combined with occupational therapy to enhance recovery in stroke survivors. It aims to determine if taVNS can lead to significant motor gains in patients with chronic stroke, specifically those with persistent arm weakness. The study will also explore predictors of brain rewiring using EEG and fMRI connectivity biomarkers. A total of 60 patients will participate in a 6-week double-masked, sham-controlled trial to assess improvements in motor function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Houston Methodist Research Institute
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Timea Hodics, MD — The Methodist Hospital Research Institute
• Study coordinator: Darrel W Cleere, MPH
• Email: dwcleere@houstonmethodist.org
• Phone: 7134413770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Stem cell therapy for chronic stroke recovery

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  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

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  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

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• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.