Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this study:
• •Deficits in language or attention that interfere with study participation
• •Severe spasticity (Modified Ashworth ≥ 3)
• •Medical or mental instability that would likely interfere with study protocol
• •Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
• •Presence of any other implanted electrical stimulation device
• •Prior injury to vagus nerve
• •Lactating, pregnant, or plan to become pregnant
• •Participation in another interventional clinical trial
• •Clinical complications that hinder or contraindicate the surgical procedure
• •Abusive use of alcohol and/or illegal substances use
• •Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
• •Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
• •Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
• •Recent history of syncope
• •Recent history of dysphagia
• •Current or anticipated requirement for diathermy
• •Uncontrolled hypertension
• •Diagnosed with Cerebral amyloid angiopathy