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

December 13, 2011 updated by: pico-tesla Magnetic Therapies, LLC

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Health Sciences Center
      • Denver, Colorado, United States, 80218
        • Mile High Research Center
      • Englewood, Colorado, United States, 80113
        • CNI Movement Disorders Center
    • Florida
      • St. Petersbury, Florida, United States, 33713
        • Suncoast Neuroscience Associates
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Michigan
      • Novi, Michigan, United States, 48337
        • Detroit Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PDQ-39 single index score
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pico-tesla Magnetic Therapies, LLC

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 17, 2009

Study Record Updates

Last Update Posted (Estimate)

December 14, 2011

Last Update Submitted That Met QC Criteria

December 13, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09026-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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