During-Procedure Activities

A. DAY 1

• 1st day of procedure administration (1st procedure administration) with the Resonator™.

B. DAY 28
The following assessment tool from the Study Test Battery will be administered following completion of the first 4 weeks of study procedure administrations.

• Parkinson’s Disease Questionnaire-39 (PDQ-39)

Post-Procedure Activities

Study post-procedure phase measurements will be conducted by the Study PI.

A. IMMEDIATE POST-PROCEDURE ASSESSMENT: STUDY ENDPOINT: DAY 57

The following assessment tools from the Study Test Battery list will be administered within four days following completion of the complete 8-week procedure administration phase.

• Unified Parkinson’s disease Rating scale (UPDRS) while the subject is in the “on” state. In subjects with motor fluctuations who are taking levodopa therapy, the subject and investigator must agree that the subject is in the “on” state for this evaluation. If the subject is not “on”, this UPDRS motor examination (part III) should be carried out later the same day after waiting for the current or subsequent doses to take effect and render the subject “on”.
• Parkinson’s Disease Non-Motor Symptom Assessment Scale
• Parkinson’s Disease Questionnaire-39 (PDQ-39)
• The Beck Depression Inventory- BDI-II
• Epworth Sleepiness Scale (ESS)
• Fatigue Severity Scale (FSS)
• Timed Finger Tapping Motor Speed Test

The following vital signs will be recorded.

• Height
• Weight
• Blood pressure
• Pulse rate

In addition, the following information will be collected:

• Unblinding assessment: The subject and the PI will be asked to state whether he or she believes that the subject was assigned to the test or to the placebo group (Resonator™ device active or inactive), and why.
• Adverse events evaluation.
• Current medication use review.

B. WASHOUT EVALUATION PHASE

The post-procedure washout phase will commence after the study procedure phase with the Resonator™ device has ended and finish when the subject has completed one month of washout period evaluations after the last study procedure was administered.

The purpose of the post-procedure phase of the study is to quantify the duration of effect of the positive gain attained through administration of the Resonator™ device.

A subject will be required to continue to maintain his or her current medication regimen through the washout evaluation phase as during the procedure administration phase. However, at any time throughout the study washout phase, if the subject’s primary treating physician believes, in his or her professional judgment, that his patient has become unstable on his or her current medication regimen, then the subject’s primary treating physician may make the required medication change at that time to return the individual to a stable state. This medication change will not affect the subject’s continued participation in the study provided that the primary treating physician notifies the study PI of the specific medication change immediately, and the PI then records this information on the subject’s case report form.

C. WASHOUT PHASE TIME POINT AND ASSESSMENTS

The washout phase assessment will occur on DAY 84 +/- 4 days (where variability is needed for ease of visit scheduling purposes).

At the washout phase assessment, the following assessment tools from the Study Test Battery list will be administered

• Unified Parkinson’s disease Rating scale (UPDRS) while the subject is in the “on” state. In subjects with motor fluctuations who are taking levodopa therapy, the subject and investigator must agree that the subject is in the “on” state for this evaluation. If the subject is not “on”, this UPDRS motor examination (part III) should be carried out later the same day after waiting for the current or subsequent doses to take effect and render the subject “on”.
• Parkinson’s Disease Non-Motor Symptom Assessment Scale
• Parkinson’s Disease Questionnaire-39 (PDQ-39)
• The Beck Depression Inventory- BDI-II
• Epworth Sleepiness Scale (ESS)
• Fatigue Severity Scale (FSS)
• Timed Finger Tapping Motor Speed Test
• Adverse events evaluation
• Current medication use review

The following vital signs will be recorded.

• Height
• Weight
• Blood Pressure
• Pulse rate

4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722

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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 patients living with Parkinson’s disease in the Tampa Bay area, Pico-Tesla Magnetic Therapies is running clinical trials to demonstrate the efficacy of the Resonator® device, which uses pulsed magnetic field therapy in treating patients with Parkinson’s disease. Subjects of the trial will be treated with the magnetic therapy device three times per week for 8 weeks with each session lasting about 1.5 hours. This new magnetic therapy focuses on improving the quality of life for people living with Parkinson’s disease by using a non-invasive approach.

Patients living in central west Florida should contact Pico-Tesla at 727-474-3722 for more information. These clinical trials will be held in the city of Clearwater, FL, located west of Tampa, and serving the counties of Pinellas, Hillsborough, Pasco and Manatee in Florida.