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PROCEDURE ADMINISTRATION PHASE
STUDY PROCEDURE ADMINISTRATION PROTOCOL
- Administration of the study procedure protocol will be overseen and directed by the study PI.
- The first study procedure with the Resonator™ device will be administered following successful completion of the 3-day standardization phase.
- The study procedure administration phase will extend over two consecutive weeks.
- Each subject will receive four study procedures with the Resonator™ device during each of the two study weeks, for a total of eight procedures.
- Each procedure administration session will last one hour and 20 minutes.
- The process for each study procedure administration session is as follows:
- The subject will remove all metal objects from their bodies, including jewelry, keys, etc.
- The subject mounts the platform and is seated within the Resonator™ device, centered between the coils.
- The Resonator™ is "activated" (procedure protocol "A" or "B") for the specified time period.
- During each study procedure administration session, the subject will refrain from listening to music or talking on the phone. Subjects may fall asleep.
- There will be minimal ferrous metals allowed in the room and no distracting noises or voices. No electrical appliances will be used nearby during study procedure administrations.
- The study procedure session is complete. The subject descends from the Resonator™.
PLEASE NOTE: THE PROCEDURE ADMINISTRATION PARAMETERS ARE CONFIDENTIAL AND PROPRIETARY INFORMATION OF THE SPONSOR, PLEASE DO NOT DISCLOSE.
Each procedure administration will follow the following output parameters protocol:
As part of the intent of this pilot study is to define optimal treatment parameters of Resonator™ therapy as a therapeutic modality for individuals with osteoarthritis, a titration process of progressively modifying the procedure parameters based upon subject response may be applied during the first 3 of the 8 procedure administrations. This titration process will work within the following parameter ranges and guidelines:
- 0.031 uG to 0.457 uG
- 0.857 Hz to 12.8 Hz
This process of ―titration‖ was effectively implemented in prior pilot studies of the impact of Magneceutical® therapy on individuals with Parkinson's disease, and reflects the process frequently employed in drug therapy or device (such as DBS) therapy clinical practice and trials that involve titration of medication selection and dosage, or amplitude/frequency and time in the case of DBS, in order to optimize effectiveness of the drug/device for the individual.
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