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Short and Long-term Responses of PD Symptoms to Earstim
Sponsor: Stoparkinson Healthcare Systems LLC
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
Conditions
Interventions
EarStim
Patients in the active arm in Period A will wear the investigational EarStim System
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
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.
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)