Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke
Condition: Stroke; Cerebrovascular Accident (CVA); Hemiparesis
MeSH terms: Stroke; Paresis
Intervention: Transcutaneous Vagus Nerve Stimulation (tVNS); Sham Transcutaneous Vagus Nerve Stimulation (tVNS)
Intervention description: tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.; tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, sham controlled treatment study in which patients will have a 50/50 chance of receiving robotic arm therapy with either active transcutaneous vagus nerve stimulation (tVNS) or sham tVNS (placebo).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Both the participants and investigators performing and analyzing clinical and objective outcome measures will remain blind to condition. Participants will be told that they have a 50-50 chance of receiving either active or sham stimulation, but they will not be told which condition they receive.
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Transcutaneous vagus nerve stimulation (tVNS); VNS; robotic therapy; occupational therapy; motor rehabilitation

Summary:

      The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus
      Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional
      recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a
      sham stimulation condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals between 18 and 85 years of age

          -  First single focal unilateral supratentorial ischemic stroke with diagnosis verified
             by brain imaging (MRI or CT scans) that occurred at least 6 months prior

          -  Cognitive function sufficient to understand the experiments and follow instructions
             (per interview with Speech Pathologist or PI)

          -  Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor
             function in the muscles of the shoulder, elbow, and wrist).

        Exclusion Criteria:

          -  Botox treatment within 3 months of enrollment

          -  Fixed contraction deformity in the affected limb

          -  Complete and total flaccid paralysis of all shoulder and elbow motor performance

          -  Prior injury to the vagus nerve

          -  Severe dysphagia

          -  Introduction of any new rehabilitation interventions during study

          -  Individuals with scar tissue, broken skin, or irremovable metal piercings that may
             interfere with the stimulation or the stimulation device

          -  Highly conductive metal in any part of the body, including metal injury to the eye;
             this will be reviewed on a case by case basis for PI to make a determination

          -  Pregnant or plan on becoming pregnant or breastfeeding during the study period

          -  Significant arrhythmias, including but not limited to, atrial fibrillation, atrial
             flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI
             review)

          -  Presence of an electrically, magnetically or mechanically activated implant (including
             cardiac pacemaker), an intracerebral vascular clip, or any other electrically
             sensitive support system; Loop recorders will be reviewed on a case by case basis by
             PI and the treating Cardiologist to make a determination