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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00841464

Enrollment

Registered

2009-02-11

Start date

2009-03-31

Completion date

2011-05-31

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Transcranial Magnetic Stimulation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Countries

United States

Outcome results