Parkinson's Disease Clinical Trial Protocol - Pico-Tesla Magnetic Therapies, LLC

		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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Our Team

Participate in our research
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Terms & Conditions of Use

Study Information
Sponsor
Monitor
Test sites and Principal Investors
Institutional Review Board
Purpose of Study
Study Overview
Labeling
Indication for Use
Regulatory Status of the Jacobson Resonator™ Device

Device Information
Device Inspection
Device Details
        Signal Generator and Attenuation circuit board
Helmholtz Coils
Comparison of Current Device with First Generation Device
Determination of Device Safety
IRB Determination of Non-Significant Risk (NSR) Status

Study Indication and Rationale,
Theory of Mechanism of Operation,
& Supporting Materials
Study Indication: Idiopathic Parkinson's Disease
Etiology
Symptoms
Currently Available Treatments
Medications
Complementary Treatments

The Resonator Device as Applied to I
mproving the signs and symptoms
of Parkinson's' Disease
Pilot Study (Phase One) Results
Pilot Study (Phase Two) Results

Study treatment modality: Electromagnetic stimulation
History Highlights
Theory of Mechanism of Operation 1
Theory of Mechanism of Operation 2
Theory of Mechanism of Operation 3

Electromagnetic Stimulation Therapy
applied to improving the signs and
symptoms of Parkinson's Disease
Rationale
Repetitive Transcranial Magnetic Stimulation (rTMS / TMS)
        State of the art of transcranial magnetic stimulation.
The current state of transcranial magnetic stimulation.
Transcranial magnetic stimulation in clinical practice.
Additional research abstracts regarding electromagnetic therapy
        Functional MRI and the impact of transcranial magnetic stimulation
BOLD MRI responses to repetitive TMS
Interleaved TMS/functional magnetic resonance imaging study.
Supporting Materials
        The application of transcranial magnetic stimulation
Influence of antiparkinsonian treatment and cortical stimulation
Long-term follow-up study with repetitive transcranial magnetic Stimulation (rTMS) in Parkinson's disease.
        Repetitive transcranial magnetic stimulation in Parkinson's disease.
Therapeutic and "dose-dependent" effect
Improvement in Parkinsonian symptoms

Other Electromagnetic Stimulation Techniques
Overall Disease Assessment
Gait
Quality of Life
Mood and Psychiatric Afflictions
Cognitive 1
Cognitive 2
Cognitive 3

Current Research
Motor Cortex Stimulation in the Treatment of Parkinson Disease
Safety Study of the Super Rapid Transcranial Magnetic Stimulation
Accelerated TMS for Parkinson's Disease With Depression

Justification and Aims for Phase Three Clinical Trial
Parkinson’s Disease Questionnaire (PDQ-39)

Study Design
Procedure Groups
Double-Blind Design
Subject procedure group randomization
Subjects
        Newsletter Ad
Compensation of Subjects
Subject Sample Size
Rationale for sample size

Study Procedure: Study Battery Test
Study Qualification Evaluation Tools
Study Efficacy Evaluation Tools

Study Procedure Protocol
Pre-Procedure Activities
        Study Qualification
Inclusion Criteria
Exclusion Criteria
Baseline Assessment
        Procedure Administration Phase
During Procedure Activities
Post Procedure Activities
End of Study Activities
Statistical Analysis Plan
Primary Efficacy outcome measure
Secondary outcome measures
Statistical methods
Statistical analysis
Post treatment (Washout) analysis
Safety analyzes
Safety and Confidentiality issues

Sponsor

Pico-Tesla Magnetic Therapies, LLC.
A subsidiary of Applied Magnetics, LLC
4700 140th Ave. N., Suite 101
Clearwater, FL 33762
Contact: Mr. Allen Braswell
Telephone: 727-474-3722
Fax: 727.474.3738
E-mail: allen_braswell@mac.com

Monitor

Regulatory Insight, Inc.
5401 S. Cottonwood Court
Greenwood Village, CO 80121
Contact: Ms. Elvira Walls, Clinical Consultant
Telephone: 303/972-5129
Fax: 720/962-5413
E-mail: elvira@reginsight.com

Test Sites and Principal Investors

The current test sites in this clinical study are as follows:

Englewood, CO
Denver, CO
Novi, Michigan

The Principal Investigator for a test site will be responsible for the oversight of the clinical study operations at that location. Each PI will be a current licensed M.D. trained and experienced in the management of patients with movement disorders.

The Principal Investigator may have suitably qualified sub-investigators and other personnel assisting him or her with carrying out the study procedures. The Principal Investigator will be responsible for the training and supervision of all personnel associated with this study.

Institutional Review Board

Independent Review Consulting, Inc.’s
Institutional Review Board
100 Tamal Plaza, Suite 158
Corte Madera, CA 94925
Phone: 415-485-0717
Fax: 415-485-0328

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.

For Parkinson’s patients living in the Denver metro area, Pico-Tesla, Magnetic Therapies is running clinical trials to demonstrate the efficacy of the Resonator™ device which uses pulsed magnetic therapy in treating Parkinson’s patients. Subjects of the trial will undergo this magnetic therapy three times per week for 8 weeks with each session lasting about 1.5 hours. This new non significant risk, non-invasive approach focuses on improving the quality of life for people living with Parkinson’s disease by using low strength magnetic fields around the body.

Those living in Clearwater, Florida should call Pico-Tesla Magnetic Therapies, LLC at 303-795-3222 for more information.