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

Status unconfirmed · Phase 3

Conditions studied: Parkinson's Disease, Quality of Life

In brief

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.

Key facts

Study ID

NCT00863226

Run by

pico-tesla Magnetic Therapies, LLC

People needed

72

Starts

2009-03-01

Expected to finish

2012-01-01

Last updated by the study team

2011-12-14

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Mile High Research Center — Denver, Colorado, United States
• CNI Movement Disorders Center — Englewood, Colorado, United States
• Suncoast Neuroscience Associates — Saint Petersbury, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Detroit Clinical Research Center — Novi, Michigan, United States

Full record on ClinicalTrials.gov

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