Status:
WITHDRAWN
Using Neuromodulation to Improve Parkinson's Disease
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson Disease
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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) pa...
Detailed Description
A double-blinded, placebo-controlled randomized trial will explore the effects of time-varying caloric vestibular stimulation (tvCVS) treatments on changes in biomarkers of neurovascular status (i.e. ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04493697
Start Date
September 1 2020
End Date
September 1 2022
Last Update
October 14 2020
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157