Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

This study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with Parkinson's Disease who have the wearing-off phenomenon on oral levodopa therapy. All participants will receive three treatments on different days, each with different stimulation conditions. All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinson's Disease for 120 minutes during each of the three treatment applications.

Keywords

Parkinson Disease Earstim - Active Stimulation

Eligibility

You can join if…

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.

You CAN'T join if...

  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.

Locations

  • University of California, San Francisco
    San Francisco California 94115 United States
  • University of Southern California
    Los Angeles California 90033 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Stoparkinson Healthcare Systems LLC
ID
NCT04652583
Phase
Phase 2
Study Type
Interventional
Last Updated