Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Cerebral Blood Flow (CBF) Perfusion
- Status
- Terminated
- Last Updated
- 8 months ago
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.
Investigators
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
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
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))