Baseline Assessment

A. VITAL SIGNS, DEMOGRAPHICS, AND PARKINSON'S DISEASE HISTORY

(i) Vital Signs
The following vital signs will be recorded for each subject:

1. Height: recorded in feet and inches
2. Weight: recorded in pounds
3. Blood pressure: Systolic and diastolic blood pressure will be measured in millimeters of mercury (mm Hg) using a sphygmomanometer
4. Pulse rate: Pulse Rate will be measured at the wrist (radial artery) using the manual palpation method. The number of beats that occur in 60 seconds will be recorded.

(ii) Demographic Variables
The following demographic variables will be recorded for each subject:

1. Gender: mail or female
2. Age
3. Ethnicity: Caucasian, Hispanic, African American, American Indian, Asian/Pacific Islander, Other

(iii) Parkinson's Disease Symptoms and History
Information on the following aspects of the subject's Parkinson's disease history will be recorded:

• Age at diagnosis of Parkinson's disease
• Total number of years since diagnosis of PD

B. BASELINE EVALUATION

The following assessment tools from the Study Test Battery will be used during Baseline Evaulation:

• 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”.
• PDQ-39: NOTE: The PDQ-39 will only be repeated during baseline evaluation if more than 10 days has passed since its administration during study qualification. Else, the PDQ-39 scores recorded during study qualification will hold for baseline
• Parkinson’s Disease Non-Motor Symptom Assessment Scale
• The Beck Depression Inventory®—II (BDI®–II): NOTE: The BDI®-II will only be repeated during baseline evaluation if more than 10 days has passed since its administration at study qualification. Else, BDI®-II score recorded during study qualification will hold for baseline.
• Epworth Sleepiness Scale (ESS)
• Fatigue Severity Scale (FSS)
• Timed finger tapping motor speed test. In subjects with motor fluctuations, this test should be administered immediately following completion of the UPDRS part III when the subject is “on”.

C. SUBJECT GROUP RANDOMIZATION

A fully qualified subject will be randomly assigned to either subject group A or group B following the methodology outlined above in the STUDY DESIGN section of the protocol.

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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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Other Forms of Deep Brain Stimulation

For Parkinson’s patients living in the Denver metro area, Pico-Tesla, Magnetic Therapies is running clinical trials to demonstrate the efficacy of the Resonator™ device which uses pulsed magnetic therapy in treating Parkinson’s patients. Subjects of the trial will undergo this magnetic therapy three times per week for 8 weeks with each session lasting about 1.5 hours. This new non significant risk, non-invasive approach focuses on improving the quality of life for people living with Parkinson’s disease by using low strength magnetic fields around the body.

Those living in northeast Colorado should call Pico-Tesla Magnetic Therapies, LLC at 303-795-3222 for more information. The clinical trials will be held in the city of Clearwater, FL.