use of a non-invasive brainstem neuromodulation device to improve neurovascular status in parkinson's disease

Conditions: Parkinson Disease

Summary: 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.

Eligibility criteria:
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

Keywords: balance disorders motor functions