Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Stroke, Upper Extremity Paresis
In brief
This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.
Key facts
- Study ID
- NCT03292159
- Run by
- Massachusetts General Hospital
- People needed
- 6
- Starts
- 2018-05-17
- Expected to finish
- 2018-11-20
- Last updated by the study team
- 2021-09-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
- Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
- Age ≥ 18;
- Able to provide written informed consent.
You may not qualify if…
- 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 Stroke Impact Scale item 7 (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.
Where it is running
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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