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
Stoparkinson Healthcare Systems LLC
90 participants
Mar 12, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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.
Exclusion Criteria17
- Patients who meet any of the following criteria are to be excluded from participation:
- Subject has a medical or psychiatric comorbidity that may compromise participation in the study.
- Subject has a history of cardiac rhythm disorders (e.g., atrial fibrillation, ventricular tachycardia, or atrioventricular block).
- Subject is pregnant or planning to become pregnant during the course of the study.
- Subject has a form of Parkinsonism other than PD, such as drug-induced Parkinsonism or Multiple System Atrophy.
- Subject is currently using on-demand medications for PD, such as subcutaneous apomorphine, sublingual apomorphine, and levodopa inhalation powder.
- Subject has an implanted deep brain stimulator (DBS).
- Subject is receiving direct intestinal infusions of levodopa.
- Subject has a history of epilepsy.
- Subject's medications are expected to change during the 90-day study period.
- Subject has a cardiac pacemaker, defibrillator, bladder stimulator, spinal cord stimulator, or any other active electronic medical device.
- Subject is unable to understand or follow the instructions required by the study.
- Subject has an ear infection or skin condition around the ear.
- Subject is participating, or has participated, in another interventional clinical trial in the last 30 days that may confound the results of this study, unless approved by the Sponsor.
- Subject has a history of brain surgery or peripheral neuropathy.
- Subject is actively using TENS or has a history of chronic TENS use within the last 2 weeks prior to study enrollment.
- Subject consumed alcohol or caffeine within 12 hours of study enrollment or has a history of alcohol dependence
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Interventions
Patients in the active arm in Period A will wear the investigational EarStim System
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
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07400731