A Phase 1/2 interventional study of Active RAVANS concurrent with arm motor training and Inactive RAVANS concurrent with arm motor training in Stroke and Upper Extremity Paresis, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Massachusetts General Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Device: Active RAVANS concurrent with arm motor training
Device: Inactive 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
Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
Upper extremity motor impairment
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Upper extremity motor function
Change in Action Research Arm Test (ARAT) score
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Grip force control
Change in accuracy, variability and temporal structure of performance on a grip force control task
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Upper extremity disability
Change in hand subtest of Stroke Impact Scale (SIS-hand) score
Time frame: Baseline to 3 months post-stroke
Mood state, anxiety and depression
Change in Hospital Anxiety and Depression Scale (HADS) scores
Time frame: Baseline to 3 months post-stroke
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital