Status:
TERMINATED
Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana Foundation, Spaulding Rehabilitation Hospital
Conditions:
Stroke
Upper Extremity Paresis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03292159
Start Date
May 17 2018
End Date
November 20 2018
Last Update
September 21 2021
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129