Pilot Study (Phase Two) Results

Title: Jacobson Resonator™: A double-blind, sham-stimulation controlled study of the application of magnetic fields using the Jacobson Resonator™ for the treatment of Parkinson’s Disease: phase two pilot study protocol. Version 2.5 dtd Oct 2007.
IRC # 07102

Primary Purpose: The main goal of the pilot study was three-fold:

1. To gain more qualitative and quantitative data across a broader number of standardized scales to validate “anecdotal” data regarding benefits reported in the phase one study (i.e. Sleep, Fatigue, Depression, Sense of Smell, reduction in Off time, etc)
2. To further develop a treatment protocol with set output parameters that can effect general improvement in Parkinson's disease signs and symptoms.
3. To determine what, if any, “placebo effect” the intervention has and to develop a proper blinding mechanism for further studies.

Study Design: This pilot study was a randomized, double-blinded, sham-stimulation controlled (two group) study.

Subject Population: Demographics of subjects in the pilot study were as follows:

• Study participation time frame: 10/07 - 4/08.
• 12 subjects total: 10 males; 2 females.
• 6 subjects in treatment group, 6 subjects in sham group.
• All 12 subjects were Caucasian.
• Average age of subjects was 69 years (SD: 4.1 years; Range: 65-72 years)
• Average age of PD symptoms onset was 56.08 years (SD: 12.91 years; Range: 20-67 years)
• Average age of PD diagnosis was 61.33 years (SD: 4.83 years; Range: 55-69 years)
• Average length of time since PD symptoms onset was 13.17 years (SD: 11.00 years; Range: 3-25 years)

Study Methodology: All subjects were treated with the active Resonator for about 1.5 hours 3x/week for 8 weeks.

Study Outcome: The treatment group demonstrated improvement over the placebo group in multiple areas of evaluation in the pilot study. No adverse effects were noted for any subject.

Key study results measured following eight weeks of stimulation in all subjects are as follows:

Subjects were evaluated monthly post-treatment for a 3 month time to washout period. The treatment group retained much of its improvement in symptoms up to 2 months after the last treatment.

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
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Patients who have been diagnosed with Parkinson’s disease, and are able to travel to Novi, Michigan, northwest of Detroit, should be aware of the clinical trials that are currently being conducted there. As part of these clinical trials, Parkinson’s patients will undergo a form of magnetic pain therapy, which requires the body to be surrounded by a low strength magnetic field. These trials will be used to test the ability of a new Resonator® device in diminishing the effects of Parkinson’s disease. Once the patient qualifies for and completes the clinical trial, they will be compensated.

Novi, Michigan is located in Oakland County and just 30 minutes northwest of Detroit. This office also serves the counties of Wayne and Macomb. Interested parties can contact Pico-Tesla for more information.