Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)

Study Overview
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Brief Summary
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An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.

Official Title
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An Open-label Extension Study for Subjects Previously Treated Either in Pilot I or Pilot II Studies of the Application of Magnetic Fields Using the Resonator for the Treatment of Parkinson's Disease.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Resonator Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior participation in pico-tesla pilot studies: NCT00779155 & NCT00863226 Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study. Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study. Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians. Adequate contraceptive measures for female subjects Capable of giving full written informed consent Exclusion Criteria: Not a participant in IRC#'s 07102 or 07021 No active brain tumors, strokes, hydrocephalus Chronic pain not associated with PD Any other condition which might prevent subject from comfortably sitting for 1.5 hours Consumption of medications that can produce Parkinsonism type symptoms Major psychiatric disturbance Epilepsy HIv and other autoimmune disorders Cancer within last 2 years History of ECt Diabetic neuropathy Uncontrolled HTN Advanced Pulmonary disease Known heart conditions such as repetitive history of cardiac arrythmias Previous surgeries for PD Prosthetics comprised of ferrous materials Stents, only where there is also cardiac arrythmias, CHF, advanced valvular stenosis, unstable vital signs, extensive ischemic damage to heart muscle as a result of one or more heart attacks. Pacemakers Uncontrolled, unstable, or untreated medical illnesses which might potentially significantly affect the patient's health in the opinion of the investigator Consumption of more than 21 alcoholic drinks per week Pregnant, breast feeding or planning pregnancy Developmental disability or cognitive impairment Inability to maintain regular medication regime Inability to abstain from partaking in new non-essential PD tx., or medications Not willing to report physician mandated changes in medication and/or treatment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Resonator magnetic field therapy<br>Administration of active magnetic fields with the Resonator Device | Device: Resonator Device<br>* active pico-tesla magnetic fields treatment for Parkinson's disease individuals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months | The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact). | baseline and 11 months |