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Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)


Brief Summary:

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


Inclusion Criteria:

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

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.

Exclusion Criteria:

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.


  • University of Southern California, Los Angeles, California, United States, 90033
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