Fibromyalgia Clinical Trial Protocol - Pico-Tesla Magnetic Therapies, LLC

		Fibromyalgia 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 Contact Information
Sponsor
Monitor
Principal Investigator
Sub-Investigators
Institutional Review Board (IRB)
Test Sites

Device Information
Device Description
Regulatory Status
Device Details
Signal Generator
Helmholtz Coils
Determination of Device Safety
IRB Determination of Device Safety

Study Information
Study Indication
Fibromyalgia: 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)
Theory of Mechanism of Operation (Part 4)
EM Stimulation Therapy Rationale
EM Stimulation Therapy: TMS/rTMS
EM Stimulation Therapy: Research (Part 1)
EM Stimulation Therapy: Research (Part 2)
Supporting Materials (Part 1)
Supporting Materials (Part 2)

Study Design
Purpose & Overview
Procedure Groups
Procedure Group Randomization
Double-Blind Design
Subjects
Study Test Battery (Part 1)
Study Test Battery (Part 2)
Study Test Battery (Part 3)
Study Test Battery (Part 4)

Study Procedures
Pre-Procedure Activities
Inclusion Criteria
Exclusion Criteria
Baseline Assessment
Standardization Phase
Study Procedure Administration Protocol
Group A Administration Protocol
Group B Administration Protocol
During-Procedure Activities
Pre- and Post-Procedure Administration Phases
Post-Procedure Activities (Part 1)
Post-Procedure Activities (Part 2)
Statistical Analysis Plan: Primary
Statistical Analysis Plan: Secondary
Safety Analysis & Early Termination
Safety and Confidentiality Issues
Informed Consent & Case Report Forms

Study Sites and Investigators

There will be at least two independent test sites in this clinical study, each with two locations as follows:

Testing Site Location: At the testing site location, the sub-PIs will conduct the study qualification evaluation and record the study outcome measures. There will be at least two testing sites in this study.
Clinical Site Location: The clinical site location will house the Resonator™ device and is where the study PI will execute the procedure administrations with the Resonator™. The clinical site location will be the same for both testing sites.

The testing and clinical site locations will be close enough to each other so that a qualifying subject who is comfortably able to travel to one of the locations will also be able to comfortably travel to the other. For any single scheduled study visit, subjects will only need to attend one of the two study site locations. During the informed consent review process, subjects will be informed of the two study site locations and when they will need to attend each.

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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.