Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Active Stimulation 20 minutes
Intramuscular stimulation
  • Device: Earstim - Active Stimulation
    Intramuscular stimulation
Active Comparator
Active Stimulation 60 minutes
Intramuscular stimulation
  • Device: Earstim - Active Stimulation
    Intramuscular stimulation
Sham Comparator
Sham Stimulation 20 minutes
Muscle-free-zone stimulation
  • Device: Earstim - Sham Stimulation
    Sham stimulation

Recruiting Locations

University of Kansas
Kansas City, Kansas 66160
Contact:
Vibhash Sharma, MD

More Details

Status
Recruiting
Sponsor
Stoparkinson Healthcare Systems LLC

Study Contact

Burak Ozsoy, PhD
+90 216 227 2700
burako@stoparkinson.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.