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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00863226
Recruitment Status : Unknown
Verified December 2011 by pico-tesla Magnetic Therapies, LLC.
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2009
Last Update Posted : December 14, 2011
Information provided by (Responsible Party):
pico-tesla Magnetic Therapies, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Quality of Life Device: Resonator Device Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Resonator Device
    Application of Magnetic Fields Using the Resonator Device

Primary Outcome Measures :
  1. Change in PDQ-39 single index score [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00863226

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United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Mile High Research Center
Denver, Colorado, United States, 80218
CNI Movement Disorders Center
Englewood, Colorado, United States, 80113
United States, Florida
Suncoast Neuroscience Associates
St. Petersbury, Florida, United States, 33713
University of South Florida
Tampa, Florida, United States, 33612
United States, Michigan
Detroit Clinical Research Center
Novi, Michigan, United States, 48337
Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
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Principal Investigator: Rajeev Kumar, MD
Principal Investigator: Jack Klapper, MD
Principal Investigator: Stephen H Schechter, MD
Principal Investigator: Olga Klepitskaya, MD
Principal Investigator: Steven Cohen, MD
Principal Investigator: Robert A Hauser, MD
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Responsible Party: pico-tesla Magnetic Therapies, LLC Identifier: NCT00863226    
Other Study ID Numbers: 09026-01
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: December 2011
Keywords provided by pico-tesla Magnetic Therapies, LLC:
Quality of Life issues in Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases