Stroke, Upper Extremity Paresis
Conditions
Keywords
stroke, vagus nerve stimulation, upper extremity paresis
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 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.
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 patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.
Interventions
DEVICEActive RAVANS concurrent with arm motor training
Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training
DEVICEInactive RAVANS concurrent with arm motor training
Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
Sponsors
Dana Foundation, Spaulding Rehabilitation Hospital
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity motor impairment | Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke | Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity motor function | Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke | Change in Action Research Arm Test (ARAT) score |
| Grip force control | Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke | Change in accuracy, variability and temporal structure of performance on a grip force control task |
| Upper extremity disability | Baseline to 3 months post-stroke | Change in hand subtest of Stroke Impact Scale (SIS-hand) score |
| Mood state, anxiety and depression | Baseline to 3 months post-stroke | Change in Hospital Anxiety and Depression Scale (HADS) scores |
Countries
United States
Outcome results
None listed