Auricular Muscle Zone Stimulation for Parkinson Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

A Multicenter, Randomized, Blinded, Electronic Device in Subjects with Parkison Disease.

Key facts

Study ID: NCT04652583
Run by: Stoparkinson Healthcare Systems LLC
People needed: 38
Starts: 2021-05-01
Expected to finish: 2022-01-05
Last updated by the study team: 2022-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is a male or female ≥18 years of age.
Subject has Parkinson's Disease and is on levodopa therapy.
Subject experiences OFF periods with an "ON" score ≥20% better than the OFF score as measured by the MDS-UPDRS motor score (MDS-UPDRS Part III).
The subject's daily "OFF" time duration is ≥2 hours per day.
The subject's Hoehn-Yahr stage when "OFF" must be less than Stage 4 (i.e., subject must be able to walk without the use of an assisted device, such as a cane or a walker).
Subject receives levodopa at least TID with a minimum of 100 mg levodopa administered with each dose.
Subject can tolerate 2 hours in an "OFF" period without requiring rescue medication.
Subject is willing and able to not change Parkinson's Disease medications or dosages during the up to 2 week study therapy period.
Subject is willing to provide Informed Consent to participate in the study.
Subject is willing and able to comply with all study procedures and required availability for study visits.

You may not qualify if…

Subject has a medical or psychiatric comorbidity that can compromise participation in the study.
Subject has cognitive dysfunction defined by a Montreal Cognitive Assessment (MoCA) score <24.
Subject has moderate levodopa-induced dyskinesias as indicated by a score >2 on items 4.1 and/or 4.2 in the MDS-UPDRS Part IV.
Subject has clinically significant depression as determined by the Beck Depression Inventory-II score >15.
Subject is pregnant as determined by a urine pregnancy test at the screening visit.
Subject is of childbearing potential and is not surgically sterilized or does not use a reliable measure of contraception.
Subject has a form of Parkinsonism other than Parkinson's Disease, such as Drug-induced Parkinsonism or Multiple System Atrophy.
Subject has an implanted deep brain stimulator (DBS).
Subject is receiving direct intestinal infusions of levodopa.
Subject has epilepsy.
Subject medications are anticipated to change during the two (2) week study period (Note: the study requires stable medications during the device testing period).
Subject has a cardiac pacemaker or defibrillator, bladder stimulator, spinal cord stimulator or other active electronic medical device.

Where it is running

University of Southern California — Los Angeles, California, United States
Rocky Mountain Movement Disorder's Center, PC — Englewood, Colorado, United States
Parkinson Disease and Movement Disorder Center of Boca Raton — Boca Raton, Florida, United States
University of Florida — Gainesville, Florida, United States
Rush University — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
University of Kansas — Kansas City, Kansas, United States
Booth Gardner Parkinson's Care Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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