Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease
Status
Conditions
Treatments
Details and patient eligibility
About
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)
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Christopher T Whitlow, MD, PhD; Richarlette C Hightower, BA
Data sourced from clinicaltrials.gov
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