Rationale

As explained above, even when treated with the best medication regimens available, Parkinson's disease patients can suffer persistent disabling symptoms or intolerable side effects that limit effective treatment of the disease. Only about 10%-15% of Parkinson's disease patients are eligible for surgical treatment options and these are in general of limited effectiveness and come with their own set of high risks and potential complications.

Consequently, there has been a recent focus to find alternative, non-invasive, non-destructive treatment options for Parkinson's disease patients that not only effectively alleviate the symptoms, but simultaneously minimize debilitating side effects and serious risks and complications.

Since 1985, thousand of subjects have been treated using magnetic stimulators to assess motor function of the peripheral and central nervous system. Resultantly, there is a considerable volume of data supporting the safety of magnetic stimulation. No serious adverse events or side effects with magnetic stimulation of the peripheral nervous system have been reported, and the incidence of reported side effects with cortical stimulation have been extremely low and well within expected norms for the respective patient groups.

The Resonator™ device, as intended for application in this clinical study, is of extremely low frequency and low amplitude (approximate frequency of 1.8 Hz to 8.0 Hz and picoTesla 10-8 gauss range) with orders of magnitude lower in field strength than the studies involving rTMS/TMS described below.

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical^®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.

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Other Forms of Deep Brain Stimulation

Clinical trials for Parkinson’s disease are currently being conducted in central west Florida. Pico-Tesla Magnetic Therapies have set up these trials to test the effectiveness of their new Resonator^® device which uses magnetic therapy in treating Parkinson’s patients.

Patients diagnosed with Parkinson’s disease, who are interested in participating in the clinical trial and able to travel to Clearwater, FL, can contact Pico-Tesla for more information. Clearwater, Florida is located about 40 minutes outside of Tampa.