Osteoarthritis Clinical Study Information - Pico-Tesla Magnetic Therapies, LLC

		Osteoarthritis Clinical Study Information The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease. Overview Device User Interface Safety and Risks FDA Clearance Overview The Resonator™ Device Compared to Other Magnetic Devices and Parkinson’s Disease Therapies The Device Versus MRI (Magnetic Resonance Imaging) The Device Versus TMS and rTMS The Device Versus Other Parkinson’s Disease Therapies Overview Jacobson Resonance™

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Study Information
Contact Information
Test Sites
Purpose & Overview
Worldwide Regulatory Status

Device Information
Device Information
Device Details
Signal Generation
Helmholtz Coils
Determination of Device Safety
Institutional Review Board (IRB)

Study Details
Study Indication
Etiology
Symptoms
Diagnosis
Treatments
Study Treatment Modality: EM Stimulation
Theory of Mechanism of Operation (Part 1)
Theory of Mechanism of Operation (Part 2)
Theory of Mechanism of Operation (Part 3)
EM Stimulation Therapy Rationale
rTMS / TMS
Research (Part 1)
Research (Part 2)
Supporting Materials (Part 1)
Supporting Materials (Part 2)
Supporting Materials (Part 3)
Supporting Materials (Part 4)

Study Design
Procedure Groups
Double-Blind Design
Subjects
Study Test Battery (Part 1)
Study Test Battery (Part 2)
Study Test Battery (Part 3)
Study Test Battery (Part 4)
Pre-Procedure Activities
Inclusion Criteria
Exclusion Criteria
Baseline Assessment

Study Procedures
Standardization Phase
Study Procedure Administration Protocol
During-Procedure Activities
Pre- and Post-Procedure Administration Phases
Post-Procedure Activities
Post-Procedure Activities (Days 15-42)
Statistical Analysis Plan
Secondary Efficacy Outcome
Statistical Methods & Analysis
Safety Analysis
Early Termination Visit
Safety and Confidentiality Issues

DEVICE DETAILS

The Resonator™ device is a device that is controlled by a computer that is connected to a magnetic therapy driver enclosure that contains a signal generator in cooperative operation with an attenuator circuit to produce a magnetic field.

A signal generator provides the “signal in” while the attenuator circuit is prepared for a helmholtz coil that is 7 feet in diameter. The resonator system is designed to create a homogeneous, isotropic magnetic field in the picoTesla (pT) range, most specifically from 1 pT to 99 pT and a frequency range from .01 Hz to 50.0 Hz (specifically for this trial); and utilizing an electrical current thereby producing a changing magnetic field in between the Helmholtz coil system. The patient may be sitting or in a supine position between the coils. The term resonance used with respect to this device refers specifically to “amplitude” resonance. Field polarity changes are to be used for the system under discussion, and limited to .1 Hz to 50.0 Hz.

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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.