Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease

July 9, 2012 updated by: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

Prospective Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease

The purpose of this research study is to test the usefulness of external magnetic stimulation (EMS) for treating the motor, cognitive, and neuropsychiatric symptoms of Parkinson's disease (PD).

Participants with Parkinson's disease will be recruited at the PADRECC of the Philadelphia VA Medical Center. Enrolled participants will be randomly assigned to receive either active external magnetic stimulation or fake stimulation. The external magnetic stimulation is delivered by wearing a helmet that is embedded with many small circuits which produce a very small magnetic field around the head. The helmet is to be worn daily for two minutes immediately before bedtime for three months in a row. The helmet is for investigational use only and has not been approved for use by the FDA.

Study Overview

Status

Completed

Conditions

Detailed Description

Current research seeks to provide a drug-free, non-invasive and non-toxic therapy for Parkinson's disease through transcranial magnetic stimulation (TMS) in the form of picoTesla magnetic therapy (pTMT). This therapy consists of an electronic device that emits magnetic flux densities that are more than ten million times lower than the magnetic flux density of the earth's magnetic field. Repetitive transcranial magnetic stimulation (rTMS) therapy aims to manipulate overall quality of life by improving motor function, as well as cognitive and neuropsychiatric symptoms such as depression.

Study Type

Observational

Enrollment (Actual)

20

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical 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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with Parkinson's disease will be recruited ONLY at the Parkinson's Disease Research, Education, and Clinical Center (PADRECC) of the Philadelphia VA Medical Center.

Description

Inclusion Criteria:

  • 40 to 80 years of age
  • Diagnosis of possible or probable PD by the UK Brain Bank clinical diagnostic criteria
  • Stable anti-Parkinsonian medical regimen for at least 30 days prior to enrollment
  • Hoehn & Yahr Scale score of I to III
  • No evidence of secondary or atypical Parkinsonism on MRI test in the past year
  • Subjects are capable of giving informed consent

Exclusion Criteria:

  • Contraindications to MRI (e.g. cardiac pacemaker, claustrophobia, metal fragments or hardware within the orbit or cranium)
  • History of stroke or TIA within the past year
  • Dementia defined as a MMSE score < 25
  • Status post deep brain stimulation surgery
  • Unstable medical conditions that would likely prevent the subject from completing the study

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

Collaborators and Investigators

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

Sponsor

Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

Collaborators

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: John E Duda, M.D., Parkinson's Disease Research, Education, and Clinical Center (PADRECC), Philadelphia
  • Principal Investigator: Timothy Roberts, Ph.D., Department of Radiology, The Children's Hospital of Philadelphia

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

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (ESTIMATE)

February 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1EA-0000071

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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