Justification and Aims for Phase Three Clinical Trial

The goals of the previous phase one and two pilot studies were met. Both quantitative and qualitative evidence was attained to support the hypothesis that the Resonator™ device would effect significant improvement in the signs and symptoms of idiopathic Parkinson's disease, and a treatment protocol with fixed output parameters was developed to this end. The data from the previous studies suggests that a broad spectrum of signs/symptoms were impacted by the intervention, that unlike current approved interventions is non-invasive, non-significant risk, and an adjunctive therapy.

Successful execution of the protocol, and achievement of primary outcome measures of the proposed phase III Clinical trial will serve to support the Sponsor’s 510(k) de Novo application for clearance by the FDA to sell the Resonator™ device, as indicated for the adjunctive treatment of some of the signs/symptoms of Parkinson’s Disease. To that end we have chosen to pursue as our primary outcome measure for this trial the Summary Index score of the PDQ-39.

4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722

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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

People who have been diagnosed with Parkinson’s disease, and are able to travel to Clearwater, Florida, should be aware of the clinical trials that are currently being conducted. During these clinical trials, Parkinson’s patients will undergo pulsed magnetic therapy, which consists of low strength magnetic fields around the body, in order to test its ability in diminishing the effects of Parkinson’s disease. Once the patient qualifies for and completes the clinical trial, they will be compensated.

Clearwater, FL is located in Pinellas County and just 40 minutes west of Tampa. This office also serves the counties of Hillsborough, Pasco and Manatee. Please contact Pico-Tesla for more information.