Purpose of Study

The purpose of this phase three clinical trial is to demonstrate the efficacy of the Resonator™ device, manufactured by pico-tesla Magnetic Therapies, LLC (the Sponsor), as an adjunctive therapy to improving aspects of health and quality of life that are relevant to patients with Parkinson's Disease. Accordingly Sponsor plans on submitting the data and analysis of this trial via a 510(k) de novo application to obtain FDA clearance to sell the device.

Study Overview

This clinical trial will evaluate a new non-invasive, non significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and/or symptoms of Parkinson’s Disease (PD).  The device utilizes patented technology involving extremely low level electromagnetic fields (EMF) to provide whole body immersion. EMF treatment with the Resonator™ device is a new technology and has shown promising results in both a Phase one open label pilot study completed in May, 2007, and a recently completed Phase two double blind, placebo controlled, randomized study.

In this double blind, randomized, placebo controlled Trial; the Study population consists of non-demented subjects with PD on stable appropriate drug therapy.  The primary outcome measure is the improvement in Subject’s Quality of Life as measured by the Summary Index score of the Parkinson’s Disease Questionnaire (PDQ-39) after 8 weeks of treatment compared to baseline. Secondary outcomes are improvement in the measures of: Mobility and ADL sub-scores as measured by the PDQ-39, depression as measured by the Beck Depression Inventory II (BDI-II), ADL as measured by the UPDRS (II) and Motor score as measured by the UPDRS (III), along with total UPDRS score including parts I-IV, fatigue as measured by the Fatigue Severity Scale, somnolence as measured by the Epworth Sleepiness Scale, non motor symptoms as measured by the PD Non Motor Symptoms Assessment Scale, and a timed finger tapping motor assessment.  The study intervention involves 3 treatment sessions per week for 8 weeks, each lasting 1 ½ hours. Thereafter, subjects will undergo evaluations over the next one month to determine the time course of treatment effect washout.

Labeling

Once the device has been cleared for market in the U.S., the device will be labeled as a prescription device, per 21 CFR § 801.109.

Indication for Use

The results of this clinical study will be used to support the following indication for use: “The Resonator™ device is indicated as an adjunctive therapy to improving aspects of health and quality of life that are relevant to patients with Parkinson's Disease.”

Worldwide Regulatory Status of the Jacobson Resonator™ Device

• The FDA responded to three separate 513(g) submissions for the Jacobson Resonator™, C030143 on October 28, 2003 and C040058 on May 14, 2004, stating that the Jacobson Resonator™ could be marketed with the labeling, “to enhance feelings of relaxation,” without filing a premarket notification or submission with FDA. The FDA also stated in these responses that they did not intend to enforce premarket requirements for this device when marketed under this indication. The Office of Device Evaluation recently confirmed in December of 2007, that this stance remains in effect.
• The Jacobson Resonator™ Model JR 18 was issued an EC Production Quality Assurance Certificate on August 1, 2001 for the therapeutic application for knee osteoarthritis; Certificate # 2001 01 0303 CP; NB # 0318.
• The Jacobson Resonator™ was issued a Health Canada Medical Device License on September 27, 2001; License Number 25852.

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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

For people living with Parkinson’s disease in the Detroit metro area, Pico-Tesla Magnetic Therapies is running clinical trials to demonstrate the efficacy of the Resonator® device which is used for pulsed magnetic field therapy. Those who qualify for this non significant risk, non-invasive procedure will be asked to sit within a low strength magnetic field three times per week for 8 weeks with each session lasting about 1.5 hours. This new magnetic therapy approach focuses on improving the quality of life for people living with Parkinson’s disease.

Patients living in southeast Michigan can call Pico-Tesla Magnetic Therapies at 303-795-3222 for more information. The clinical trial itself will be held at their office in Novi, Michigan, which is located northwest of Detroit, and serving the counties of Oakland, Wayne, and Macomb in Michigan.