|
|||||||||||
|
DOUBLE-BLIND DESIGNThis study will be a double-blind design, such that neither the subject nor the investigators will be aware of to which group (test or placebo) the subject has been assigned until after the study is complete and the final data set has been analyzed. The EMF (the therapeutic modality) generated from the Resonator™ device when activated does not cause any detectable light, heat, sound, vibration or other sensation that may enable an individual to distinguish between whether the device is truly activated or not. Each subject will be randomly assigned to either Procedure Group A or Procedure Group B. For the purpose of this study, a computer will control and contain the procedure parameters determined by the sponsor to relate to each procedure group. For each session, the subject’s ID number will determine whether procedure ‘A’ or procedure ‘B’ will be selected depending on the subject’s group assignment. Only the study Sponsor will know which procedure (‘A’ or ‘B’) corresponds to the true test procedure (Resonator™ device activated) and which corresponds to the fake (placebo) procedure (Resonator™ device not activated) until the study is complete. The Sponsor will insure that this information is stored and maintained confidentially at the Sponsor’s work site. This knowledge will not be shared with any of the investigative parties, the subjects or the study monitor until the final subject data set has been analyzed. The sham (placebo treatment group) setting has been designed such that the device will operate identically to when the device is in the active (test treatment group) setting from both the subject’s and the device operator’s perspectives. The only difference between the sham and test procedure parameters will be the sham treatment will send no electricity to the coils, and therefore create no magnetic field. Regardless of ‘A’ or ‘B’ setting, the device operator will be prompted to enter the same treatment procedure output variables and other information needed to run the device. The procedure timer will be ‘activated’ and ‘click off’ when finished in both instances. All operational sounds (such as clicking ‘on’ and ’off,’) will be identical between settings. The electromagnetic field (the therapeutic modality) generated from the Resonator™ device when activated does not cause any detectable light, heat, sound, vibration or other sensation output that may enable an individual to distinguish between whether the device is truly activated or not. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
Copyright © 2009 by Pico-Tesla. All rights reserved
|
The Resonator™ device is an Investigational Device limited by Federal (or United States) |
About Us | Our Team | Participate In Our Research | News Releases | Terms & Conditions of Use |
