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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00841464
• Lead Sponsor: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Study Start: 2009-03
• Study Completion: 2011-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Philadelphia VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States