NCT07400731

Short and Long-term Responses of PD Symptoms to Earstim

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Stoparkinson Healthcare Systems LLC · Industry
• Sex: All
• Age: 44 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
DEVICE	EarStim	Patients in the active arm in Period A will wear the investigational EarStim System
DEVICE	Sham 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
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2026-02-10
• Last updated: 2026-02-17

Locations

2 sites across 1 country: Turkey (Türkiye)