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

Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease

This study is a single-site, double-blinded, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD)

Patients treating twice daily using a non-invasive brainstem modulation device. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD.

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 in an 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'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
• Ongoing symptoms from a COVID-19 infection that includes one or more of the exclusion criteria listed above
• 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