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

Inclusion Criteria:

• Must be 21-85 years old

• Diagnosed with Parkinson's Disease

• Within driving distance of Atrium Health Wake Forest Baptist (Winston-Salem, NC)

• Responsive to Parkinson's medication for a minimum of 3 years

• Have ability to reliably use the investigational device

• Understand and complete all assessments (provided in English only)

• Be able to have 3 separate MRI scans (1.5 hours per MRI)

• Have a study partner/regular caregiver that is willing to participate in the trial

• Demonstrate moderate burden of motor symptoms and non-motor symptoms

• Consent to being videotaped during motor examination visit

• Willing to answer questions related to sexual interest, arousal and performance inan interview with study staff

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'sdisease, multiple sclerosis, ALS, atypical Parkinsonism, or aneurysm

• History or evidence of unstable mood disorder or demonstrates evidence ofsuicidality

• Hearing aids that are implanted or cannot be easily removed and replaced, such ascochlear 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 trialwithin the last 30 days

• Taking medication for vomiting or nausea more than 2 times per week, consistently

• Ongoing symptoms from a COVID-19 infection that includes one or more of theexclusion criteria listed above

• Planned surgery scheduled to occur during the clinical trial that requires sedationand/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