Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease

Exclusion Criteria

• •Cannot attend all study visits (4 on-site visits) or complete all study activities
• •Heart attack, angina, or stroke within the past year
• •Use medications that regulate heart rate
• •Have a history or prior diagnosis of dementia
• •Receiving deep brain stimulation therapy
• •Treated with a pump for continuous delivery of dopamine replacement therapy
• •Use of Apomorphine rescue
• •Works night shifts
• •Have any significant co-morbidity such as stroke, brain tumor, epilepsy, Alzheimer's disease, multiple sclerosis, ALS, atypical Parkinsonism, or aneurysm
• •History or evidence of unstable mood disorder or demonstrates evidence of suicidality
• •Hearing aids that are implanted or cannot be easily removed and replaced, such as cochlear implants
• •Chronic ringing in the ears for more than 3 months
• •Diagnosed with traumatic brain injury with ongoing symptoms
• •Recent history of substance abuse and/or dependence (alcohol or other drugs)
• •Diagnosed balance dysfunction
• •Eye surgery within the previous 3 months
• •Ear surgery within the previous 6 months
• •Active ear infection, perforated tympanic membrane, or inner ear inflammation
• •Recent history of frequent ear infections (≥ 1 per year over the past two years)
• •Contraindications for MRI scans, such as metal implants or a pacemaker
• •Currently enrolled or have participated in another interventional clinical trial within the last 30 days
• •Taking medication for vomiting or nausea more than 2 times per week, consistently
• •Planned surgery scheduled to occur during the clinical trial that requires sedation and/or would typically be followed with a prescription for pain management
• •Women who are pregnant or plan to become pregnant during the the study
• •Women of child-bearing potential (i.e., are not yet 3 years removed from their first menopausal symptom), who are not abstinent or exclusively in same sex relationships must:
• •Test negative for pregnancy as indicated by a negative urine pregnancy test
• •Agree to use an approved contraception method