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NOT YET RECRUITING
NCT07400731
NA

Short and Long-term Responses of PD Symptoms to Earstim

Sponsor: Stoparkinson Healthcare Systems LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

44 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-02

Completion Date

2027-02

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DEVICE

EarStim

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

DEVICE

Sham 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

DEVICE

EarStim + 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.

OTHER

Standard 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.

Locations (2)

Koc University Hospital

Istanbul, Turkey (Türkiye)

Şişli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)