Study Indication and Rationale, Theory of Mechanism of Operation, & Supporting Materials

The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease.

 

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Study Information
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Monitor
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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
Stud 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

 

 

 
   

Procedure Groups

This study is a placebo-controlled, randomized, double-blind parallel group multiple center design.

There will be two procedure groups in this study, with an equal number of subjects assigned to each of the two groups, as follows:

Test group: Subjects in the test group will receive the actual procedure with the Resonator™ device activated.

Placebo (control) group: Subjects in the placebo group will receive a ‘sham’ procedure with the Resonator™ device not activated.

Apart from the distinction of whether or not the subject receives procedures with the Resonator™ device activated, all subjects and the investigative parties will adhere to all phases of the entire protocol design.

 
 

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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.
 

About Us | Our Team | Participate In Our Research | News Releases | Terms & Conditions of Use
Patients & Caregivers | Physicians & Medical Providers | Research & Publications | Press Kit & News | FDA Approval Status
The Device Overview | The Device | User Interface | Safety and Risks | FDA Clearance
Neuromodulation & Electromagnetics Overview | The Resonator™ Device Compared to MRI | The Resonator™ Device Versus TMS and rTMS
The Resonator™ Device Compared to Other Parkinson's Disease Therapies | Theory of Mechanism Overview | Jacobson Resonance™
Parkinson's Disease Study | Alzheimer's Disease Study | Fibromyalgia Disease Study | Osteoarthritis Disease Study
Pico-Tesla’s Resonator™ Magnetic Therapy Device | Resonator™ Magnetic Therapy Device | A Complementary and Alternative Medicine
Complementary and Alternative Therapy | Magnetic Resonance Therapy | Conditions Treated with Magnetic Therapy
Other Forms of Deep Brain Stimulation
 

Patients who are diagnosed with Parkinson’s disease, and able to travel to Clearwater, Florida, should be aware of the clinical trials that are currently being conducted there. The clinical trial requires a patient to be exposed to a low strength magnetic field in order to test its ability in diminishing the symptoms of Parkinson’s. Once the patient qualifies for and completes the clinical trial, they will be compensated.

Interested parties can contact Pico-Tesla for more information.