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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Current Research

The following is a collection of research studies that are in progress or planned pertaining to the application of electromagnetic stimulation for the relief of Parkinson's disease symptoms.

  1. Safety Study of the Super Rapid Transcranial Magnetic Stimulation in Patients with Parkinson's Disease
    Sponsoring Institute: National Institute of Neurological Disorders and Stroke (NINDS)

    Super rapid transcranial magnetic stimulation (srTMS) is a method of brain stimulation that may be able to change the electrical activity of the nerve cells of the brain. It has been proposed and tested as a treatment for brain disorders, including Parkinson's disease.

    The purpose of this study is to use a device called the magnetic stimulator to investigate the safe limit of srTMS, such as intensity of stimulation and the number of magnetic pulses that may lead to excessive brain stimulation. The srTMS treatment is performed by placing an insulated coil of wire on the scalp and passing a very brief electrical current through the coil.

    Rationale for Study: The treatment of Parkinson's disease (PD) needs further improvement, particularly in the areas of gait and freezing. A promising technique is repetitive transcranial magnetic stimulation (rTMS) that, so far, has produced small effects on bradykinesia in drug free patients in limited trials. The 50 Hz srTMS frequency proposed here is in a range that exceeds the currently established guidelines since such high frequencies have not been investigated.

    Ten patients with Parkinson's disease-whose main problems are slowness of movement and difficulty walking will participate in this study. They will be asked to come to the laboratory for one experiment. Before and after srTMS treatment, investigators will test participants' brain function with a series of psychological tests and an EEG (electroencephalogram). The srTMS treatment is performed by placing an insulated coil of wire on the scalp and passing a very brief electrical current through the wire coil. The experiment will last 2 to 4 hours. Subjects will be men and women aged 40 to 80 years with DOPA-responsive, akinetic-rigid Parkinson's disease.

    Subjects will be randomly assigned to one of two treatment groups: one will receive rTMS to parts of the brain involved in controlling movement; the other will receive sham, or placebo, stimulation. Nine treatments will be given over a 4-1/2 week period. Patients will take their medications during the study, but will stop taking them four to five hours before one of the sessions. For rTMS, an insulated wire coil is placed on the scalp. A short electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The pulses are delivered in short bursts, lasting one second each. There will be 48 bursts for a total of 1200 pulses per 24-minute session. The stimulation may cause muscle twitching in the scalp or face and may also cause small movements of the limbs.


 
 

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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.

 
 

All physicians in Pinellas, Hillsborough, Pasco and Manatee County, Florida, who have patients diagnosed with Parkinson’s disease, should know that Pico-Tesla Magnetic Therapies are currently conducting clinical trials. Parkinson’s patients will be subject to low strength pulsed magnetic fields around the body using the new Resonator® device. This is a paid clinical trial for all patients who qualify for and complete the procedure.

Pico-Tesla is holding these clinical trials in their Clearwater, FL office. Clearwater is located on the west coast of Florida, just 240 minutes west of Tampa. Any interested party can contact Pico-Tesla for more information.