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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

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

Fed

Collaborators

Children's Hospital of Philadelphia

Registry information

Official study title

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

Important dates

Study start: 2009
Study completion: 2011
First posted: Feb 11, 2009
Registry last updated: Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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