Short and Long-term Responses of PD Symptoms to Earstim

NCT07400731 | Recruiting

• 1 other identifier: STP-PD-006
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

parkinson disease; intrinsic auricular muscle zone stimulation; IAMZ

Outcome Measures

Primary Outcomes (2)

• Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III scores

  Comparison of reduction in the MDS-UPDRS Part III scores from pre-stimulation to 40 minutes post-stimulation between active and sham arms during Period A. 18 items, 0-4 rating scale (from normal to worse).

  40 minutes

• Adverse events

  Frequency of all adverse events

  From enrollment to the end of study at 90 days

Secondary Outcomes (3)

• Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score

  90 minutes

• Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score

  From 30 days (Visit 2) to 90 days (Visit 4)

• Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score

  90 days

Other Outcomes (13)

• Patient Global Impression - Change (PGI-C) scale

  40 minutes

• Clinical Global Impression - Change (CGI-C) scale

  40 minutes

• Parkinson's Disease Questionnaire (PDQ-8)

  From 30 days (Visit 2) to 90 days (Visit 4)

Study Arms (2)

Active arm (Period A)

EXPERIMENTAL

Patients in the active arm in Period A will wear the investigational EarStim System

Device: EarStim; Device: EarStim + Standard of care (SOC)

Sham arm (Period A)

SHAM COMPARATOR

Patients in the sham arm in Period A will wear an identical device with no active stimulation.

Device: Sham device; Other: Standard of Care (SOC)

Interventions

EarStim DEVICE

Patients in the active arm in Period A will wear the investigational EarStim System

Active arm (Period A)

Sham device 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

Sham arm (Period A)

EarStim + Standard of care (SOC) DEVICE

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.

Active arm (Period A)

Standard of Care (SOC) OTHER

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.

Sham arm (Period A)

Eligibility Criteria

• Age: 44 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stoparkinson Healthcare Systems LLC: lead

Study Sites (2)

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Şişli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof

  Stoparkinson Healthcare Systems LLC

  STUDY DIRECTOR

Central Study Contacts

Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof

CONTACT

02108797738; ycakmak@stoparkinson.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Period A of the study will be double-blind, randomized, sham-controlled. Participant and investigator will be blinded. Period B will be open label and SOC-controlled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)