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

 

 

 
   

Study Test Battery

The following is a listing of all of the tests, questionnaires, scales and indices that will be used in this study, for test and placebo subjects alike. For each study phase, the precise tests, questionnaires, scales and indices from this list that will be employed will be specified.

  • Medical History: Medical history recording for the subject will include detailed collection of the following information as it pertains to determination of satisfaction of study qualification criteria:

    • Previous and current medical conditions
    • Previous and current medical procedures

  • Physical Examination: Physical examination of the subject will include evaluation of the following aspects of a subject’s health status as they pertain to determination of satisfaction of study qualification criteria:

    • EENT
    • Cardiovascular
    • Peripheral Vascular
    • Pulmonary
    • Hepato-Gastrointestinal
    • Renal/GU
    • Metabolic/Endocrine
    • Hematological, Lymph Nodes
    • Dermatological
    • Neurological
    • Psychiatric
    • Musculoskeletal
    • Other, as applicable

  • Neurological Examination: Neurological examination of the subject will include evaluation of the following aspects of a subject’s neurological function as they pertain to determination of satisfaction of study qualification criteria:

    • Mental Status
    • Cranial Nerve Function
    • Plantar Reflex
    • Deep Tendon Reflexes
    • Muscle Strength
    • Gait
    • Coordination, Balance
    • Involuntary Movements
    • Sensory Perception
 
 

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.
 

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
 

Clinical trials for Parkinson’s disease are currently being conducted in central west Florida. Pico-Tesla Magnetic Therapies have set up these trials to test the effectiveness of their new Resonator® device which uses magnetic therapy in treating Parkinson’s patients.

Patients diagnosed with Parkinson’s disease, who are interested in participating in the clinical trial and able to travel to Clearwater, FL, can contact Pico-Tesla for more information. Clearwater, Florida is located about 40 minutes outside of Tampa.