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Study of Magnetic Fields for Treatment of Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779155
First Posted: October 24, 2008
Last Update Posted: July 12, 2011
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.
Information provided by:
pico-tesla Magnetic Therapies, LLC
  Purpose
The purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of Parkinson's disease.

Condition Intervention Phase
Parkinson's Disease Device: The Resonator Device: The Resonator control Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Sham-stimulation Controlled Study of the Application of Magnetic Fields Using the Jacobson Resonator for the Treatment of Parkinson's Disease.

Resource links provided by NLM:


Further study details as provided by pico-tesla Magnetic Therapies, LLC:

Primary Outcome Measures:
  • Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State. [ Time Frame: Baseline and 8 weeks ]
    The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.


Enrollment: 12
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inactive Resonator Therapy
Inactive magnetic resonance therapy
Device: The Resonator control
inactive magnetic field therapy with placebo fields
Active Comparator: Active Resonator Therapy
active magnetic resonance therapy
Device: The Resonator
active magnetic field therapy

  Eligibility

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.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopathic PD with motor fluctuations of at least 3-4 hours daily., Subject on levodopa, subject is ambulatory, maintain regular med schedule, willing and able to abstain from new PD treatments, Able to demonstrate correct completion of PD diaries, non-demented, adequate contraceptive measures, capable of giving full written consent.

Exclusion Criteria:

  • any factors that will prevent subject from completing full course of therapy with the resonator, any factors preventing subject from attending clinic in the "off" state, atypical parkinsonism, no active brain tumors, strokes, hydrocephalus, any other neurologic or non-neurologic disorder which might affect the symptomatic expression of pts. parkinsonism, suffers from chronic pain, no meds that may produce parkinsonism, no psychiatric disturbance, Epilepsy, HIV, Cancer, History of ECT, Diabetic Neuropathy, Uncontrolled HTN, Advanced Pulmonary Disease, Known heart conditions such as cardiac arrythmias, previous PD surgical interventions, prosthetics comprised of ferrous metals, pacemakers, DBS, Uncontrolled, unstable or untreated medical illnesses, Consumption of more than 21 alcoholic drinks per week, Pregnant, breast feeding, developmental disability
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00779155


Locations
United States, Colorado
pico-tesla Magnetic Therapies
Littleton, Colorado, United States, 80120
Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
  More Information

Publications:
O. Klepitskaya, R. Kumar, Efficacy and Safety of Low Level Electromagnetic Fields Treatment in Parkinson's Disease. Movement Disorders; Vol. 23, No. 11, 2008, pp. 1628-1637

Responsible Party: pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT00779155     History of Changes
Other Study ID Numbers: PD pilot 2
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: May 13, 2011
Results First Posted: July 8, 2011
Last Update Posted: July 12, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases