Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

Inclusion Criteria:

• History of unilateral supratentorial ischemic stroke that occurred at least 6 months but not more than 10 years prior to enrollment.

• Age >40 years and <80 years.

• Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 20 to 50 (inclusive of 20 and 50).

• Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.

• Right- or left-sided weakness of the upper extremity.

Exclusion Criteria

• Participant has implanted metallic or electronic devices in the head or neck

• Hemorrhagic stroke or a heterogenous lesion etiology

• Participant has a cardiac pacemaker or implanted or wearable defibrillator

• Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous

• Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease

• Participant has a fever or shows clinical signs concerning for an infectious disease

• Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study

• Low heart rate (<60 bpm) from a cardiac conduction block or related etiology

• Participant has a history of trigeminal neuralgia

• Participant has a history of Bell's Palsy

• History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve

• History of recurrent syncopal events

• Known or newly-discovered aneurysm or arteriovenous malformation

• Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days

• Botox injections 12 weeks prior to or during therapy