RecruitingNot ApplicableNCT07400731

Short and Long-term Responses of PD Symptoms to Earstim

Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease

Sponsor

Stoparkinson Healthcare Systems LLC

Enrollment

90 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

PARKINSON DISEASE (Disorder)

Summary

This is a prospective, multicenter, randomized, two-period study designed to evaluate the safety and effectiveness of the EarStim System for intermittent relief of motor symptoms in patients with Parkinson's disease experiencing wearing-off phenomena. Adult patients with moderate to severe Parkinson's disease (MDS-UPDRS Part III score ≥33) receiving oral dopaminergic therapy will be enrolled. Period A is a randomized, double-blind, sham-controlled phase conducted in a clinical setting. Period B is an unblinded, standard-of-care-controlled phase evaluating the effectiveness of the EarStim System during home use over 90 days.

Eligibility

Min Age: 44 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called EarStim, a medical device called EarStim + Standard of care (SOC), and others for people with parkinson disease (disorder). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 44 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEarStim

Patients in the active arm in Period A will wear the investigational EarStim System

DEVICESham device

Patients in the sham arm in Period A will wear an identical device with no active stimulation, programmed in similar manner as the EarStim system

DEVICEEarStim + Standard of care (SOC)

Participants in the active arm in Period A who are responders to stimulation (based on reduction in MDS-UPDRS III scores) will proceed to Period B, which takes place in a home setting. In Period B, these responders will be assigned to "EarStim + SOC" group. They will be instructed to continue their oral dopaminergic medications as usual, and in addition, to use EarStim stimulation at home at the time of their medication intake.

OTHERStandard of Care (SOC)

Participants from the sham arm of Period A will be assigned to the "SOC" group and will continue their oral dopaminergic medications as usual, without any EarStim stimulation.