Procedure Administration Phase

A. GENERAL ASSESSMENT CONDITIONS

Subjects will be required to maintain their regular Parkinson's disease medication and dosage schedule throughout the study.

Subjects must agree to not change or start taking any new medications or other new treatments, or to change the dosages they take of current medications, for Parkinson's disease during the course of the study.

Subjects must agree to notify the study investigator immediately if there are any PD or non-PD medication or dose changes.

B. STUDY PROCEDURE ADMINISTRATION PROTOCOL

Administration of the study procedure protocol will be overseen and directed by the study Principal Investigator. The first study procedure with the Resonator™ device will be administered within 7 days of the Baseline Evaluation being completed.

The study procedure administration phase will extend over eight weeks. Each subject will receive three study procedures with the Resonator™ device per week for eight consecutive weeks for a total of 24 procedures. Each study procedure administration will last up to 1½ hours in total, and will have 4 exposure sessions. The process that each subject will undergo for each study procedure administration session is typically described as follows:

1. The subject mounts the platform and is seated within the Resonator™ device and centered between the coils.
2. The Resonator™ device is ‘activated’ (procedure administration protocol ‘A’ or ‘B’ according to the subject’s randomized group assignment) for the specified time period during the initial study procedure administration.
3. The subject has a rest period of specified duration during which the Resonator™ device is inactive.
4. The subject is repositioned within the Resonator™ device and again centered between the coils.
5. The Resonator™ device is activated for the specified time period during the second study procedure administration.
6. The subject has a rest period of specified duration during which the Resonator™ device is inactive.
7. The subject is repositioned within the Resonator™ device and again centered between the coils.
8. The Resonator™ device is activated for the specified time period during the third study procedure administration.
9. The subject has a rest period of specified duration during which the Resonator™ device is inactive.
10. The subject is repositioned within the Resonator™ device and again centered between the coils.
11. The Resonator™ device is activated for the specified time period during the fourth study procedure administration.
12. The study procedure session is complete. The subject descends from the Resonator™ device.

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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.

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Pico-Tesla’s Resonator™ Magnetic Therapy Device | Resonator™ Magnetic Therapy Device | A Complementary and Alternative Medicine
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Other Forms of Deep Brain Stimulation

For people living with Parkinson’s disease in the Detroit metro area, Pico-Tesla Magnetic Therapies is running clinical trials to demonstrate the efficacy of the Resonator® device which is used for pulsed magnetic field therapy. Those who qualify for this non significant risk, non-invasive procedure will be asked to sit within a low strength magnetic field three times per week for 8 weeks with each session lasting about 1.5 hours. This new magnetic therapy approach focuses on improving the quality of life for people living with Parkinson’s disease.

Patients living in southeast Michigan can call Pico-Tesla Magnetic Therapies at 303-795-3222 for more information. The clinical trial itself will be held at their office in Novi, Michigan, which is located northwest of Detroit, and serving the counties of Oakland, Wayne, and Macomb in Michigan.