Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.

Detailed Description
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This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.

Official Title
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A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol

Conditions
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Parkinson's Disease, Quality of Life

Intervention / Treatment
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* Device: Resonator Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's Disease Stable optimized anti-PD drugs for at least 4 weeks PDQ-39 Summary Index between 15 and 45 Ambulatory Willing to maintain regular medication regime throughout study Able to abstain from starting in new treatments to improve PD symptoms during course of study. No prior surgical interventions for Parkinson's Disease Non-demented Minimum of 30 years of age, but not older than 85 Capable of giving full written consent Exclusion Criteria: Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc. Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism. Consumption of medications that can produce drug induced parkinsonism Chronic pain not associated with PD Current or past history of major psychiatric disturbance No typical or non-typical anti-psychotics for treatment of drug induced psychosis. Chronic fatigue Epilepsy or history of epilepsy Seizures or taking medication for epilepsy HIV or other autoimmune disorders History of ECT Uncontrolled hypertension Advanced pulmonary disease Unstable cardiac disease Prior surgical interventions for Parkinson's disease Prosthetics or implants comprised of ferrous metals Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain Pregnant, breast feeding or planning pregnancy prior to study end Dementia, developmental disability, psychiatric disorder or other cognitive impairment Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Resonator Device|Application of Magnetic Fields Using the Resonator Device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PDQ-39 single index score |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life issues in Parkinson's disease