Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Cerebral Blood Flow (CBF) Perfusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cerebral Blood Flow (CBF) Perfusion
Time Frame: 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
Time Frame: 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 Outcomes
- Percent Change in Functional Connectivity(baseline and end of treatment (week 12))