Non-invasive vagus nerve stimulation for stroke recovery
Non-invasive VNS in Stroke Recovery
NA · The Methodist Hospital Research Institute · NCT06761404
This study is testing if a new non-invasive treatment using vagus nerve stimulation can help stroke survivors with arm weakness recover better when combined with occupational therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06761404 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have experienced ischemic or hemorrhagic strokes more than 6 months prior and have persistent arm weakness.
Not a fit: Patients with severe cognitive deficits, bilateral paresis, or those with conditions unrelated to stroke recovery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor recovery in stroke patients, enhancing their quality of life.
How similar studies have performed: While the approach of using taVNS is relatively novel, similar neuromodulation techniques have shown promise in enhancing recovery in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, taVNS, trans-auricular, non-invasive vagus nerve stimulation, stroke recovery, neuromodulation, rehabilitation, chronic stroke