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

NCT ID: NCT00841464

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Parkinson's disease Transcranial Magnetic Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

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

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John E Duda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Parkinson's Disease Research, Education, and Clinical Center (PADRECC), Philadelphia

Timothy Roberts, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, The Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1EA-0000071

Identifier Type: -

Identifier Source: org_study_id