NCT04652583

Auricular Muscle Zone Stimulation for Parkinson Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Stoparkinson Healthcare Systems LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Earstim - Active Stimulation	Intramuscular stimulation
DEVICE	Earstim - Sham Stimulation	Sham stimulation

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2020-12-03
• Last updated: 2022-01-11

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study