Study of Magnetic Fields for Treatment of Parkinson's Disease

A Double-blind, Sham-stimulation Controlled Study of the Application of Magnetic Fields Using the Jacobson Resonator for the Treatment of Parkinson's Disease.

The purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: The Resonator control; Device: The Resonator

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Littleton, Colorado, United States, 80120
      • pico-tesla Magnetic Therapies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.	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.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: pico-tesla Magnetic Therapies, LLC

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 23, 2008
• First Posted (Estimate): October 24, 2008

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD pilot 2