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

  • STATUS
    Recruiting
  • End date
    May 25, 2022
  • participants needed
    22
  • sponsor
    Wake Forest University Health Sciences
Updated on 16 April 2021

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)

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.

Details
Condition Parkinson's disease
Treatment Non-invasive brainstem stimulation
Clinical Study IdentifierNCT04598828
SponsorWake Forest University Health Sciences
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be 21-85 years old
Diagnosed with Parkinson's Disease (meeting UK PD Society Brain Bank criteria)
Responsive to oral DRT (dopamine replacement therapy) for a minimum of 3 years and on a stable dose of therapy
Must be able to voluntarily give written informed consent
Must have ability to reliably use the investigational device
Must be able to understand and complete all assessments (provided in English only) within a given on-state period
Must be willing and able to undertake a ~1 hour imaging session in a MRI magnet with a head coil in place during 3 separate clinic visits
Must have a home partner and/or regular caregiver
Must have capability to complete assessments using telemedicine platforms
Must demonstrate moderate burden of motor symptoms and non-motor symptoms in PD ( MDS-UPDRS part II >12 and MDS-UPDRS part I scores >10)
Must consent to being videotaped during motor examination visit

Exclusion Criteria

Pregnant women or women who intend to get pregnant during the course of the study
Have experienced a heart attack, angina or stroke within the past 12 months
Use of medications that regulate heart rate
Have a history or prior diagnosis of dementia or adjusted score 20 on the Montreal Cognitive Exam at the baseline visit
Those receiving deep brain stimulation
Treated with a pump for continuous delivery of DRT (Dopamine replacement therapy)
Use of Apomorphine rescue
Works night shifts
Have a major concomitant illness or illnesses including cancer or disease of the cardiovascular, respiratory and/or renal systems
Has history or evidence of unstable mood disorder, or demonstrates evidence of suicidality
Those with hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
Those who have persistent negative sequela of a traumatic brain injury
Those who have been diagnosed with another neurological illness with the exceptions of restless leg syndrome and REM behavioral sleep disorder
Those with a recent history of substance abuse and/or dependence (alcohol or other drugs)
Those who have a diagnosed vestibular dysfunction and/or balance dysfunction
Those who have had eye surgery within the previous three months or ear surgery within the previous six months
Those who have inner ear pathology, such as active and/or frequent ear infections or reported damage to the tympanic membrane or have labyrinthitis
Those who have contraindications for MRI imaging, such as metal implants or a pacemaker that would preclude the MRI scan
Those who have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
Those who are taking antiemetics chronically (more than 2 times per week, consistently)
Have sequelae from a COVID-19 infection that includes one or more of the exclusion criteria listed above
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