Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

Not yet recruiting

Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Unilateral middle cerebral artery ischemic stroke incurred 4-30 days prior;
- Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3 (scale 0-4);
- At least partial grasp and release of contralesional hand defined by FMA-UE items 8a and 8b each score ≥ 1 (scale 0-2);
- Age 40-82;
- Able to provide written informed consent.

Exclusion Criteria

- Implanted electronic device (e.g., pacemaker, neurostimulator);
- Pregnancy;
- Major psychiatric or medical condition that could interfere with study participation;
- Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
- Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by SIS-hand mean score < 4 (scale: 0-5);
- History of seizure during year before stroke or > 1 post-stroke seizure;
- Significant cognitive or language impairment that would interfere with informed consent or study participation;
- Severe dysphagia;
- Bradycardia defined as resting heart rate < 50 bpm;
- Nonsustained ventricular tachycardia;
- Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome);
- History of asystole;
- History of recurrent vaso-vagal syncope;
- Hypotension defined as blood pressure < 90/60 mmHg.