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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841464
• Other study ID #: 1EA-0000071
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: July 9, 2012
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Philadelphia VA Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States,