Secondary Outcome Measures

The following secondary efficacy outcome measures will be evaluated in this study for differences between active treatment and placebo groups:

Mean change from baseline to endpoint in:

• Mobility subscale score on the PDQ-39.
• ADL subscale score on the PDQ-39.
• Score on the UPDRS subscale II (Activities of Daily Living -ADL).
• Score on the UPDRS subscale III (Motor)
• Total Score of the UPDRS subscales I-IV
• Score on the Beck Depression Inventory-II® (BDI-II®).
• Timed Finger Tapping Motor Speed test score
• Fatigue Severity Scale (FSS).
• Epworth Sleepiness Scale (ES).
• Parkinson’s Disease Non-Motor Symptom Assessment Scale

STATISTICAL METHODS

Efficacy analysis will be according to the intent to treat (ITT) principle by last observation carried forward (LOCF).

Intent to Treat: Subjects will be included in the ITT analysis if they were randomized to study treatment group, had a valid baseline visit including fully completed UPDRS, PDQ-39 and BDI-II® tools and had received at least the first four week’s study treatment (12 out of 24 treatments).

Last observation carried forward: Missing data will be handled by carrying forward the last observation.

Per-protocol analysis will also be performed for the set of all subjects who were randomized to treatment group and completed the study according to the protocol.

STATISTICAL ANALYSIS

The primary analysis of efficacy will be through parametric analysis of covariance (ANCOVA) model.

The parametric ANCOVA model will be applied with the mean change from baseline to endpoint in summary index score on the PDQ-39 (PDQ-39SI) as the dependent variable, procedure group as the independent variable of interest and baseline PDQ-39SI score as a covariate. A two-tailed significance level of 5.00% will be considered to be statistically significant.

Secondary Measures Analysis

The secondary measures are continuous variables and will be analyzed through parametric analysis using ANCOVA. A two-way significance level of 5% will be considered to be statistically significant.

To control for type-I error due to multiple endpoint testing, analysis of secondary endpoints will be done according to a hierarchical method of analysis, with the testing of each successive endpoint only being undertaken if the previous endpoint showed a significant difference versus placebo. The prespecified hierarchical order, with the testing to be terminated at the first nonsignificant result is change in:

• Total Score of the UPDRS subscales I-IV
• Score on the UPDRS subscale II (Activities of Daily Living -ADL).
• Score on the UPDRS subscale III (Motor)
• Score on the Beck Depression Inventory-II® (BDI-II®).
• Mobility subscale score on the PDQ-39.
• ADL subscale score on the PDQ-39.
• Parkinson’s Disease Non-Motor Symptom Assessment Scale
• Fatigue Severity Scale (FSS).
• Epworth Sleepiness Scale (ES).
• Timed Finger Tapping Motor Speed test score

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Other Forms of Deep Brain Stimulation

Doctors located in Clearwater, Flordia, who have patients living with Parkinson’s disease, should know that Pico-Tesla Magnetic Therapies is currently conducting clinical trials. They are testing a new Resonator® device which uses a form of pulsed magnetic therapy. This clinical trial involves the use of low strength magnetic fields in hopes of diminishing the symptoms of Parkinson’s. This is a paid clinical trial for all patients who qualify for and complete the procedure.

Pico-Tesla is holding these clinical trials in their Clearwater, FL office. Any interested party can contact Pico-Tesla for more information.