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

Trial details

Who runs it

Wake Forest University Health Sciences

Trial code

NCT04598828

Record updated

14 August 2025

Original description

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)Read full original descriptionShow less

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)

Inclusion: 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: Have a history or prior diagnosis of dementia; Receiving deep brain stimulation therapy; Treated with a pump for continuous delivery of dopamine replacement therapy; Hearing aids that are implanted or cannot be easily removed and replaced, such as cochlear implants; Eye surgery within the previous 3 months; Ear surgery within the previous 6 months; Contraindications for MRI scans, such as metal implants or a pacemaker; 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; Heart attack, angina, or stroke within the past year; Use medications that regulate heart rate; 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; Recent history of substance abuse and/or dependence (alcohol or other drugs); Active ear infection, perforated tympanic membrane, or inner ear inflammation; Recent history of frequent ear infections (≥ 1 per year over the past two years); Ongoing symptoms from a COVID-19 infection that includes one or more of the exclusion criteria listed above; Cannot attend all study visits (4 on-site visits) or complete all study activities; Use of Apomorphine rescue; Works night shifts; Chronic ringing in the ears for more than 3 months; Diagnosed with traumatic brain injury with ongoing symptoms; Diagnosed balance dysfunction; Currently enrolled or have participated in another interventional clinical trial within the last 30 days; 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.

ClinicalTrials.gov NCT04598828