Clinical trial NCT04598828: Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease
Official title: Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: balance disorders
motor functions
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Change in cerebral blood flow (CBF) perfusion
timeFrame: baseline
measure: Change in cerebral blood flow (CBF) perfusion
timeFrame: end of treatment (week 12)
measure: Change in cerebrovascular Reactivity
timeFrame: baseline
measure: Change in cerebrovascular Reactivity
timeFrame: end of treatment (week 12)
Secondary outcomes:
measure: Change in functional connectivity
timeFrame: baseline and end of treatment (week 12)
Other outcomes:
measure: Change in cerebral haemodynamics
timeFrame: baseline and end of treatment (week 12)
measure: Durability of change of cerebral blood flow (CBF) perfusion
timeFrame: baseline and the post-treatment follow-up (week 17)
measure: Durability of change of cerebrovascular Reactivity
timeFrame: baseline and the post-treatment follow-up (week 17)
measure: Durability of change of functional connectivity
timeFrame: baseline and the post-treatment follow-up (week 17)
measure: Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: baseline, end of treatment (week 12), and the post-treatment follow-up (week 17)
measure: Change in the Timed Up and Go Test
timeFrame: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)
measure: Change in the Montreal Cognitive Assessment
timeFrame: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)
measure: Change in the Non-Motor Symptom Scale
timeFrame: Change between the baseline and end of treatment (week 12) measure.
measure: Change in the Non-Motor Symptom Scale
timeFrame: Change between the baseline and the post-treatment follow-up (week 17) measure.
measure: Change in the Geriatric Depression Scale
timeFrame: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)
measure: Change in the Parkinson's Anxiety Scale
timeFrame: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)
measure: Change in the Epworth Sleepiness Scale
timeFrame: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)
measure: Change in the Functional Assessment of Chronic Illness Therapy - Fatigue
timeFrame: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)
measure: Change in Arterial Stiffness
timeFrame: baseline and end of treatment (week 12)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christopher T Whitlow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: