Study of Magnetic Fields for Treatment of Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT00779155
First received: October 22, 2008
Last updated: July 7, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 22, 2008
Results First Received: May 13, 2011
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014