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

Stoparkinson Healthcare Systems

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Device: Earstim - Sham Stimulation; Device: Earstim - Active Stimulation

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04652583

STP-PD-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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38 participants in 3 patient groups

Active Stimulation 20 minutes

Active Comparator group

Description:

Intramuscular stimulation

Treatment:

Device: Earstim - Active Stimulation

Active Stimulation 60 minutes

Active Comparator group

Description:

Intramuscular stimulation

Treatment:

Device: Earstim - Active Stimulation

Sham Stimulation 20 minutes

Sham Comparator group

Description:

Muscle-free-zone stimulation

Treatment:

Device: Earstim - Sham Stimulation