Actively Recruiting
Short and Long-term Responses of PD Symptoms to Earstim
Led by Stoparkinson Healthcare Systems LLC · Updated on 2026-04-23
90
Participants Needed
2
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short and Long-term Responses of PD Symptoms to Earstim
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 44 years or older.
- Diagnosed with Parkinson's disease and on stable carbidopa/levodopa therapy for at least 4 weeks before enrollment.
- Willing and able to keep Parkinson's medications unchanged during the 90-day study.
- Experience both ON and OFF episodes as measured by MDS-UPDRS Part IV with a score of 1 or more.
- Experience OFF periods with an ON score at least 20% better than OFF score by MDS-UPDRS Part III one hour after medication.
- Have an MDS-UPDRS Part III score of 33 or higher during OFF periods.
- Agree to remain in an OFF period for up to 3 hours without rescue medication.
- Can walk independently without assistive devices during ON and OFF periods.
- Willing to provide informed consent and comply with study procedures and visits.
You will not qualify if you...
- Have medical or psychiatric conditions that could interfere with study participation.
- History of heart rhythm disorders such as atrial fibrillation, ventricular tachycardia, or atrioventricular block.
- Pregnant or planning pregnancy during the study.
- Have Parkinsonism other than Parkinson's disease, including drug-induced Parkinsonism or Multiple System Atrophy.
- Currently using on-demand Parkinson's medications like apomorphine or levodopa inhalation.
- Have an implanted deep brain stimulator.
- Receiving direct intestinal levodopa infusions.
- History of epilepsy.
- Expect medication changes during the 90-day study.
- Have cardiac pacemaker, defibrillator, bladder stimulator, spinal cord stimulator, or other active electronic medical devices.
- Unable to understand or follow study instructions.
- Have an ear infection or skin condition around the ear.
- Participated in another interventional trial within 30 days unless approved.
- History of brain surgery or peripheral neuropathy.
- Active or recent (within 2 weeks) use of TENS therapy.
- Consumed alcohol or caffeine within 12 hours before enrollment or history of alcohol dependence.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
2
Şişli Hamidiye Etfal Research and Training Hospital
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
Research Team
Y
Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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