Fibromyalgia Clinical Study Information


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

 

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Study Design

Subjects

  • Subjects will be 30 individuals who voluntarily sign the subject informed consent form and subsequently satisfy the study qualification criteria.
  • Subjects will be randomized into one of the three study procedure groups (2 active and one placebo).
  • All Resonator procedure administrations and study evaluations will be performed at a single test site location under one Principal Investigator.

Subject Recruitment
Subjects will be recruited from:

  1. among the investigator‟s pool of existing and new patients with fibromyalgia.
  2. individuals who respond to the following newspaper ad.

Fibromyalgia Research Study

This study is to see if the Resonator™, a non-invasive, investigational device that uses low-level magnetic fields, can help to decrease pain and other symptoms of Fibromyalgia.
The study involves 10 visits to a test site over 2 ½ weeks

Please contact pico-tesla Magnetic Therapies, LLC
at Phone number here or
email address here for details

MAY EARN UP TO $250
FOR QUALIFIED SUBJECTS

Compensation of Subjects
A subject may be compensated up to $250 for his or her participation in this study, as follows:

  1. A subject who qualifies for study participation and is enrolled in the study, completes all eight Resonator procedure administration visits, and records all study measures, as applicable, through completion of the study endpoint visit on Day 14 will receive $200.
  2. A subject who completes and submits to the test site all of the post-study materials through to the one-month time point will receive an additional $50.

In addition, a subject will not be charged for the cost of the study procedures with the Resonator™ device or for the cost of any other directly-related evaluations or measurements that occur as part of his or her participation in the study.

Subject Sample Size
There will be 30 subjects enrolled in this pilot study at a single test site: 10 in each of Procedure Groups A, B and C.


 
 

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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.