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CLINICAL RESEARCH

Earstim Features

The development process of the Earstim is still in progress; new features continue to be added. Apart from this, the sale of the device is not possible yet, as required certifications must first be acquired. It is targeted to be made available for patients within 2 years.

About the Earstim;

  • It is an electro-stimulator which applies low current to the relevant area.
  • It is protected with a patent.
  • It is noninvasive.
  • It can be easily attached and detached from the ear.
  • It is effective, with proven short-term effects.
  • No side effects have been reported.
  • The patient can use it easily by pressing just one button.
  • Appropriate for mobile use throughout the day as it is very lightweight and battery-operated.
  • The doctor can easily adjust patient’s parameters with a mobile application via Bluetooth.

Publications

The results of the Short-term Effect Clinical Trials were published in June 2017 as an article in a highly regarded journal in this field, called Frontiers’ in Human Neuroscience.

The title of the article is “Rapid Alleviation of Parkinson’s Disease Symptoms via Electrostimulation of Intrinsic Auricular Muscle Zones;” details of which can be accessed  here.

International Clinical Trials

In this study, the effects of the device will be measured on over 150 patients over a 6 month period in America and Europe. This study also carries significance in terms of the certification process. This study is aimed to start in the year 2019.

Long-term Effect Clinical Trial

To understand the effects of the long-term use of the device on symptoms, a clinical trial was conducted with the participation of 14 patients at Koc University Hospital. The results were very positive and will be published in an article soon. 

Mechanism of Action Study

To understand which areas of the brain the device is stimulating, a clinical trial has been conducted with 12 patients at the Koc University hospital. MRI images of patients before and after stimulation were obtained and differences were recorded. The results of the study are being analyzed.

Short-term Effect Clinical Trial

The short term effects of the device on patients have been studied in a clinical trial concurrently conducted by I.U. Cerrahpasa Hospital and Koc University Hospital with the participation of 24 patients. In this study, 20 mins of stimulation was applied to patients and upon observing the patients’ for the following 50mins, symptoms were measured by expert professors with a UPDRS score. In addition to this, with movement recording sensors, the changes in the movements of patients were monitored with mathematical models.

The results of the bio-statistical analyses resulted in a UPDRS score of 5.7 points in patient symptoms upon short-term use; that is, the same level as L-dopa based medication. Also, side effects which are observed with use of medication were not recorded. The results of this study were published in the journal Frontiers in Human Neuroscience; the details of which can be accessed from the Publications section.