EarStim for short- and long-term relief of Parkinson's motor symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter study enrolls adults with moderate-to-severe Parkinson's disease on stable carbidopa/levodopa who experience ON/OFF wearing-off. Period A is a randomized, double-blind, sham-controlled in-clinic phase comparing EarStim to a sham device for immediate motor effects. Period B is an unblinded, standard-of-care-controlled phase in which participants use the EarStim system at home for 90 days to evaluate longer-term effectiveness and safety. The device targets intrinsic auricular muscle zones (IAMZ) via non-invasive high-frequency stimulation to engage brainstem and basal ganglia motor pathways.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

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

Where it's running

• Koc University Hospital
  Istanbul, Turkey (Türkiye) Recruiting
• Şişli Hamidiye Etfal Research and Training Hospital
  Istanbul, Turkey (Türkiye) Not yet recruiting

Study contacts

• Study coordinator: Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof
• Email: ycakmak@stoparkinson.com
• Phone: 02108797738

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.