Stroke Clinical Trial
Official title:
Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke
Verified date | September 2021 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | November 20, 2018 |
Est. primary completion date | November 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Spaulding Rehabilitation Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Dana Foundation, Spaulding Rehabilitation Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Upper extremity motor impairment | Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score | Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke | |
Secondary | Upper extremity motor function | Change in Action Research Arm Test (ARAT) score | Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke | |
Secondary | Grip force control | Change in accuracy, variability and temporal structure of performance on a grip force control task | Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke | |
Secondary | Upper extremity disability | Change in hand subtest of Stroke Impact Scale (SIS-hand) score | Baseline to 3 months post-stroke | |
Secondary | Mood state, anxiety and depression | Change in Hospital Anxiety and Depression Scale (HADS) scores | Baseline to 3 months post-stroke |
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