---
title: Relieve movement symptoms between doses
nct_id: NCT07400731
phase: NA
status: RECRUITING
sponsor: Stoparkinson Healthcare Systems LLC
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07400731"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07400731"
last_fetched: "2026-05-10T14:07:53.016Z"
source: "Parkinson's Pathways (curated)"
---
# Relieve movement symptoms between doses

**Goal (in five words):** Relieve movement symptoms between doses

**Official Title:** Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease

**Trial ID:** [NCT07400731](https://clinicaltrials.gov/study/NCT07400731)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Stoparkinson Healthcare Systems LLC
- **Target Enrollment:** 90 participants
- **Start Date:** 2026-03-12
- **Completion Date:** 2027-01
- **Conditions:** PARKINSON DISEASE (Disorder)
- **Interventions:** EarStim, Sham device, EarStim + Standard of care (SOC), Standard of Care (SOC)
- **Intervention Types:** DEVICE, OTHER

## Summary For Families

Aiming to reduce OFF time and improve motor function during OFF periods for people with Parkinson's who still get ON/OFF fluctuations despite levodopa. EarStim delivers mild electrical pulses to muscles around the ear to influence brain movement circuits, it is used with your regular carbidopa/levodopa and is meant to boost motor control without changing medication doses. Looking for adults 44 and up on a stable carbidopa/levodopa regimen who have measurable ON/OFF swings, can walk without assistance, are willing to keep meds unchanged for the 90-day study and tolerate up to three hours in an OFF state, and who do not have implanted stimulators, certain cardiac or seizure disorders, or use on-demand rescue infusions or apomorphine.

## Eligibility

- **Minimum age:** 44 Years
- **Sex:** ALL

### Full Criteria

```
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
```

## Locations (2)

- Koc University Hospital, Istanbul, Turkey (Türkiye) _(41.0138, 28.9497)_
  - Fatoş Sibel Ertan, MD, Professor of Neurology — (CONTACT) — +902124678700 — sertan@ku.edu.tr
  - Fatoş Sibel Ertan, MD, Professor of Neurology — (PRINCIPAL_INVESTIGATOR)
- Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey (Türkiye) _(41.0138, 28.9497)_
  - Gençer Genç, MD, Professor of Neurology — (CONTACT) — +902123735000 — gencerg@gmail.com
  - Gençer Genç, MD, Professor of Neurology — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof — (CONTACT) — 02108797738 — ycakmak@stoparkinson.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07400731*  
*HTML version: https://parkinsonspathways.com/trial/NCT07400731*  
*Source data: https://clinicaltrials.gov/study/NCT07400731*