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
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Signal Generation
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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

Subjects

Subjects will be up to 30 adults who voluntarily sign the subject informed consent form and subsequently satisfy the study qualification criteria for osteoarthritis of the hip, and other parameters pertinent to this pilot study.

Subjects will be randomized into one of the two study procedure groups.

Regardless of procedure group assignment, all subjects will adhere to all aspects of the pilot study protocol.

Subject Recruitment

Subjects will be recruited from

(i) among the investigator‘s pool of existing and new patients with osteoarthritis of the hip.

(ii) individuals who respond to the following newspaper ad.

Compensation of Subjects

A subject may receive up to $250 for his or her participation in the study, as follows:

Upon qualification for study participation and enrollment in the study a subject will receive $20.
Upon completion and submission to the test site of all materials for the 3-Day Standardization Phase, as applicable, a subject will receive $20.
Following completion of each one of the eight Resonator™ procedure administration visits and recording of all related study measures for the visit, as applicable, a subject will receive $20 (for a maximum total of $160 for completion of all 8 procedure administration visits).
Upon completion of all of the post-study activities and submission of those materials to the test site, as applicable, through to the one-month post-procedure time point, a subject will receive $50.

In addition, a subject will not be charged for the cost of the study procedures with the Resonator™ device or for the cost of any other directly-related evaluations or measurements that occur as part of his or her participation in the study.

Subject Sample Size
There will be up to 30 subjects enrolled in this pilot study: up to 15 in each procedure group.

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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.