Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease
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.
⁃ Patients fulfilling the following criteria are eligible for participation:
• Subject must be ≥44 years of age.
• Subject has PD and is on stable carbidopa/levodopa therapy for at least four weeks prior to enrollment in the study.
• Subject must be willing and able to refrain from changing PD medications or dosages during the 90-day study.
• Subject reports experiencing both ON and OFF episodes (MDS-UPDRS Part IV - Time Spent in the OFF-state score ≥1), as assessed and determined by the investigator.
• \*This corresponds to item 4.3 in MDS-UPDRS Part IV, where a score of 0 (zero) indicates that the subject experiences no OFF periods during the waking day, and a score of ≥1 reflects the presence of OFF periods at any level.
• Subject experiences OFF periods with an ON score that is ≥20% better than the OFF score, as measured by the MDS-UPDRS Part III score, 1 hour after taking their dose of carbidopa/levodopa.
• Subject has an MDS-UPDRS Part III score ≥33 in OFF period.
• Subject agrees to remain in an OFF period for up to 3 hours without requiring rescue medication.
• Subject can walk independently, without the use of an assisted device (e.g., cane or walker), in both ON and OFF periods.
• Subject is willing to provide informed consent to participate in the study.
• Subject is willing and able to comply with all study procedures and required availability for study visits.