Study of Magnetic Fields for Treatment of Parkinson's Disease

Parkinson's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779155
• Other study ID #: PD pilot 2
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2008
• Last updated: July 7, 2011
• Start date: August 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2011
• Source: pico-tesla Magnetic Therapies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• The Resonator
active magnetic field therapy
• The Resonator control
inactive magnetic field therapy with placebo fields

Locations

Country	Name	City	State
United States	pico-tesla Magnetic Therapies	Littleton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
pico-tesla Magnetic Therapies, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No