VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

Exclusion Criteria

• •1. History of hemorrhagic stroke
• •2. Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
• •3. Significant sensory loss.
• •4. Presence of ongoing dysphagia or aspiration difficulties.
• •5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
• •6. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.
• •7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
• •8. Severe depression
• •9. Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
• •10. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
• •11. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
• •12. Pregnant or plan on becoming pregnant or breastfeeding during the study period
• •13. Currently require, or likely to require, diathermy during the study duration
• •14. Any health problem requiring surveillance with MRI imaging
• •15. Active rehabilitation within 4-weeks prior to therapy
• •16. Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
• •17. Severe spasticity of the upper limb