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

Not Applicable

Terminated

Conditions: Parkinson Disease

Registration Number: NCT04598828

Lead Sponsor: Wake Forest University Health Sciences

Brief 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)

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cerebral Blood Flow (CBF) Perfusion	end of treatment (week 12)	Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion
Cerebrovascular Reactivity	end of treatment (week 12)	Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system

Secondary Outcome Measures

Name	Time	Method
Percent Change in Functional Connectivity	baseline and end of treatment (week 12)	Changes to the within-network connectivity of the DMN (Default Mode Network)

Trial Locations

Locations (1): Wake Forest Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Wake Forest Health Sciences
🇺🇸Winston-Salem, North Carolina, United States