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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
ClinicalTrials.gov Identifier:
NCT00841464
First received: February 10, 2009
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia:

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: May 2011
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841464

Locations
United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
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
  More Information

No publications provided

Responsible Party: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
ClinicalTrials.gov Identifier: NCT00841464     History of Changes
Other Study ID Numbers: 1EA-0000071
Study First Received: February 10, 2009
Last Updated: July 9, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia:
Parkinson's disease
Transcranial Magnetic Stimulation

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

ClinicalTrials.gov processed this record on May 16, 2013