Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Active RAVANS concurrent with arm motor training Device
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: RAVANS
  • In-active RAVANS concurrent with arm motor training Device
    Intervention Desc: Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
    ARM 1: Kind: Experimental
    Label: Sham stimulation
  • Inactive RAVANS concurrent with arm motor training Device
    Intervention Desc: Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
    ARM 1: Kind: Experimental
    Label: Sham stimulation

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper extremity motor impairment Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary Upper extremity motor function Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary Grip force control Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary Upper extremity disability Baseline to 3 months post-stroke
Secondary Mood state, anxiety and depression Baseline to 3 months post-stroke

Sponsors