Auricular Muscle Zone Stimulation for Parkinson Disease

Open to people ages 18 years and up

1. Subject is a male or female ≥18 years of age.
2. Subject has Parkinson's Disease and is on levodopa therapy.
3. 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).
4. The subject's daily "OFF" time duration is ≥2 hours per day.
5. 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).
6. Subject receives levodopa at least TID with a minimum of 100 mg levodopa administered with each dose.
7. Subject can tolerate 2 hours in an "OFF" period without requiring rescue medication.
8. Subject is willing and able to not change Parkinson's Disease medications or dosages during the up to 2 week study therapy period.
9. Subject is willing to provide Informed Consent to participate in the study.
10. . Subject is willing and able to comply with all study procedures and required availability for study visits.

1. Subject has a medical or psychiatric comorbidity that can compromise participation in the study.
2. Subject has cognitive dysfunction defined by a Montreal Cognitive Assessment (MoCA) score <24.
3. 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.
4. Subject has clinically significant depression as determined by the Beck Depression Inventory-II score >15.
5. Subject is pregnant as determined by a urine pregnancy test at the screening visit.
6. Subject is of childbearing potential and is not surgically sterilized or does not use a reliable measure of contraception.
7. Subject has a form of Parkinsonism other than Parkinson's Disease, such as Drug-induced Parkinsonism or Multiple System Atrophy.
8. Subject has an implanted deep brain stimulator (DBS).
9. Subject is receiving direct intestinal infusions of levodopa.
10. . Subject has epilepsy.
11. . Subject medications are anticipated to change during the two (2) week study period (Note: the study requires stable medications during the device testing period).
12. . Subject has a cardiac pacemaker or defibrillator, bladder stimulator, spinal cord stimulator or other active electronic medical device.