Clinical trial NCT00841464: Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease
Official title: Prospective Study on the Effect of External Magnetic Stimulation on Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Transcranial Magnetic Stimulation
Lead sponsor: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
Sponsor class: FED
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2009-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
Study officials:
affiliation: Parkinson's Disease Research, Education, and Clinical Center (PADRECC), Philadelphia
name: John E Duda, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiology, The Children's Hospital of Philadelphia
name: Timothy Roberts, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: