Alzheimer's Clinical Study Information


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

 

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Titration Description for Active Treatment Groups (Two Groups)

For the purpose of clarity, we will refer to these two active treatment groups as Group 1 and Group 2 (although this numbering has no significance on the actual randomization process). Group 1 and Group 2 will receive treatment within the following parameters:

Range of flux density (B) of magnetic fields

  • 7 X 10-8 gauss - 5 X 10-7 gauss

Range of frequencies (f) for magnetic fields

  • 2 Hertz - 280 Hertz

Exposure time for each total treatment session will be about 60-90 minutes (including breaks for the subject).

To ensure consistency in each of these two active treatment groups, whatever range finding studies are done initially in each group, they will be repeated for every other patient in the group for consistency. After the first 2-3 weeks of participation of the first subject in each group, a simpler, reductive standardized protocol will be used for every treatment session remaining for every patient in that group. In this manner, every subject in each group will have received exactly the same protocol. There will be no variation of signal parameters, sequence of signals or timing of signals, from patient to patient within the groups

Adjustments as to signal parameters, sequence and timing will be considered as each signal is tested. It is the experience of the study consultant that subject responsiveness to measures described below is relatively quick when a signal is resonant.

Various standard objective measures will be undertaken throughout the course of study, such as drawing a clock or a house, providing words that begin with a particular letter or belong in a particular category, completing a maze or number cancellation task, or copying figures. For example, a subject might be asked to complete an exercise before any treatment is administered; and then asked to repeat the same exercise after exposure to a particular signal parameter.

Until Group 1 and Group 2 treatment protocols are established with the first subject, additional subjects cannot be placed into the group.


 
 

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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.