PARKINSON DISEASE (Disorder)NCT07400731
Short and Long-term Responses of PD Symptoms to Earstim
A study testing EarStim in people with PARKINSON DISEASE (Disorder), run by Stoparkinson Healthcare Systems LLC at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 44 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- EarStim
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Mar 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Koc University Hospital
Istanbul, 34010
Fatoş Sibel Ertan, MD, Professor of Neurology, +902124678700, sertan@ku.edu.tr
Fatoş Sibel Ertan, MD, Professor of Neurology
- Not yet recruiting
Şişli Hamidiye Etfal Research and Training Hospital
Istanbul
Gençer Genç, MD, Professor of Neurology, +902123735000, gencerg@gmail.com
Gençer Genç, MD, Professor of Neurology
About this study
Official title: Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease
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.
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting approximately 0.3% of the general population and up to 3% of individuals over 65. It is characterized by cardinal motor symptoms such as bradykinesia, rigidity, tremor, and postural instability. While levodopa remains the gold-standard treatment, long-term use often leads to motor complications, including fluctuations between "ON" and "OFF" states. Deep brain stimulation of the subthalamic nucleus is an effective intervention for motor symptoms and medication-induced complications; however, axial symptoms such as postural instability and gait disturbances remain resistant to treatment. Alternative approaches, including peripheral nerve stimulation, have been explored to modulate motor control regions of the brain, offering potential benefits for PD symptom management.
The EarStim System, developed by Stoparkinson Healthcare Systems, is a wearable, non-invasive electro-stimulator designed to target intrinsic auricular muscle zones (IAMZ). These zones are innervated by the trigeminal, facial, vagus, and C2 spinal nerves, creating connections with motor regulatory pathways in the brainstem and basal ganglia. Pilot studies suggest that high-frequency stimulation of IAMZ can alleviate PD motor symptoms beyond the stimulation period.
This study aims to evaluate the safety and effectiveness of the EarStim System for intermittent symptom relief in PD patients. The study is a prospective, multi-center, randomized, two-period, non-significant risk pivotal study involving patients with PD experiencing wearing-off phenomena. It is designed to assess the safety and effectiveness of the EarStim System for the intermittent relief of motor symptoms. The study will recruit adult patients with moderate to severe PD, defined as an MDS-UPDRS Part III score of ≥33, who are being treated with oral dopaminergic medication.
The study consists of two periods: Period A and Period B. Period A will be a double-blind, randomized, sham-controlled part to assess the safety and effectiveness of the EarStim System in a clinical setting at Visit 1 (Day 0). Period B will be unblinded and controlled by a SOC arm to evaluate the effectiveness of the EarStim System in a home setting over a 90-day period.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- EarStim, Sham device, EarStim + Standard of care (SOC), Standard of Care (SOC)
- Keywords
- parkinson disease, intrinsic auricular muscle zone stimulation, IAMZ
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarStimDevice
Patients in the active arm in Period A will wear the investigational EarStim System
Sham deviceDevice
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
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active arm (Period A) | Experimental | Patients in the active arm in Period A will wear the investigational EarStim System Receives: 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. Receives: Device: Sham device; Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 40 minutes
Adverse events
Frequency of all adverse events
Measured: 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
Comparison of reduction in the MDS-UPDRS Part III scores from pre-stimulation to 90 minutes post-stimulation, comparing the active and sham arms during Period A (Visit 1).
18 items, rating 0-4 score for each item (from normal to worse)
Measured: 90 minutes
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score
Mean reduction in the MDS-UPDRS Part III score from pre-stimulation to 40 minutes post-stimulation in the EarStim + SOC group compared with SOC group at Visit 2,3,4.
18 items, rating 0-4 score for each item (from normal to worse)
Measured: 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
Non-inferiority of the mean reduction in the MDS-UPDRS Part III score from pre-stimulation to 40 minutes post-stimulation in the EarStim + SOC group at Visit 4 compared with the active group at Visit 1.
18 items in scale, 0-4 rating score for each item (from normal to worse)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start12 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stoparkinson Healthcare Systems LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof, Study director, Stoparkinson Healthcare Systems LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400731
- Sponsor's protocol ID
- STP-PD-006
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07400731
- Acronym / sponsor ID
- STP-PD-006
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- parkinson disease, intrinsic auricular muscle zone stimulation, IAMZ
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stoparkinson Healthcare Systems LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting approximately 0.3% of the general population and up to 3% of individuals over 65. It is characterized by cardinal motor symptoms such as bradykinesia, rigidity, tremor, and postural instability. While levodopa remains the gold-standard treatment, long-term use often leads to motor complications, including fluctuations between "ON" and "OFF" states. Deep brain stimulation of the subthalamic nucleus is an effective intervention for motor symptoms and medication-induced complications; however, axial symptoms such as postural instability and gait disturbances remain resistant to treatment. Alternative approaches, including peripheral nerve stimulation, have been explored to modulate motor control regions of the brain, offering potential benefits for PD symptom management.
The EarStim System, developed by Stoparkinson Healthcare Systems, is a wearable, non-invasive electro-stimulator designed to target intrinsic auricular muscle zones (IAMZ). These zones are innervated by the trigeminal, facial, vagus, and C2 spinal nerves, creating connections with motor regulatory pathways in the brainstem and basal ganglia. Pilot studies suggest that high-frequency stimulation of IAMZ can alleviate PD motor symptoms beyond the stimulation period.
This study aims to evaluate the safety and effectiveness of the EarStim System for intermittent symptom relief in PD patients. The study is a prospective, multi-center, randomized, two-period, non-significant risk pivotal study involving patients with PD experiencing wearing-off phenomena. It is designed to assess the safety and effectiveness of the EarStim System for the intermittent relief of motor symptoms. The study will recruit adult patients with moderate to severe PD, defined as an MDS-UPDRS Part III score of ≥33, who are being treated with oral dopaminergic medication.
The study consists of two periods: Period A and Period B. Period A will be a double-blind, randomized, sham-controlled part to assess the safety and effectiveness of the EarStim System in a clinical setting at Visit 1 (Day 0). Period B will be unblinded and controlled by a SOC arm to evaluate the effectiveness of the EarStim System in a home setting over a 90-day period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm (Period A) | Experimental | Device: EarStim, Device: EarStim + Standard of care (SOC)Patients in the active arm in Period A will wear the investigational EarStim System |
| Sham arm (Period A) | Sham comparator | Device: Sham device, Other: Standard of Care (SOC)Patients in the sham arm in Period A will wear an identical device with no active stimulation. |
Who may qualify
- Ages
- 44 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarStimPatients in the active arm in Period A will wear the investigational EarStim System | Device | Active arm (Period A) |
| Sham devicePatients in the sham arm in Period A will wear an identical device with no active stimulation, programmed in similar manner as the EarStim system | Device | Sham arm (Period A) |
| EarStim + Standard of care (SOC)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. | Device | Active arm (Period A) |
| Standard of Care (SOC)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. | Other | Sham arm (Period A) |
Primary outcome
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III scores
Time frame: 40 minutes
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).
Adverse events
Time frame: From enrollment to the end of study at 90 days
Frequency of all adverse events
3 secondary outcomes
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score
Time frame: 90 minutes
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III score
Time frame: 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
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof study director
Stoparkinson Healthcare Systems LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EarStim in people with PARKINSON DISEASE (Disorder), run by Stoparkinson Healthcare Systems LLC at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Özgür Çakmak, MD, PhD, Assoc.Prof (02108797738, ycakmak@stoparkinson.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III scores (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.