Using Neuromodulation to Improve Parkinson's Disease

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Parkinson Disease

In brief

This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD) patients treating twice daily time-varying caloric vestibular stimulation treatment using a solid-state 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 will be compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD. The durability of effects will be evaluated at a post-treatment assessment conducted five weeks after treatment cessation.

Key facts

Study ID: NCT04493697
Run by: Wake Forest University Health Sciences
People needed: 0
Starts: 2020-09-01
Expected to finish: 2022-09-01
Last updated by the study team: 2020-10-14

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

Pregnant women.
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 responds affirmatively to question #9 on the BDI-II (any score > 0 on suicidal thoughts or wishes). Participants that respond affirmatively to this question should receive a referral for mental health counseling according to the mandates of the IRB or ethics review committee.
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) due to known interference with the vestibular response to caloric stimulation

Where it is running

Wake Forest Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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