Effect of Stimulus Rate on Cognitive and Motor Activity in Young Subjects, Elderly Subjects, and Patients With Parkinson's Disease
NCT ID: NCT00026598
Last Updated: 2008-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2001-10-31
2003-11-30
Brief Summary
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There are two parts to the study: behavioral tests and functional magnetic resonance imaging (fMRI). All participants will be asked about their medical history, have a physical examination, and complete a questionnaire. They must not take regular medications, including levodopa and dopamine agonists, for 8 hours prior to the study.
The behavioral study involves computer-generated neuropsychological tasks, including hand movements, imagination of movements, and mental calculations. Response will be recorded and evaluated. Electrodes may be placed on the participant's skin to measure surface electromyogram (EMG).
The fMRI study involves MRI scanning in which motor and thinking tasks are performed. Electrodes may be placed on the skin to monitor muscle activity.
Thirty patients, ages 40 and up, with early-stage Parkinson's disease will be recruited. Sixty normal volunteers ages 21-75 will be included as well for comparison.
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Detailed Description
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Conditions
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Eligibility Criteria
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Inclusion Criteria
Thirty PD patients with age 40 and higher will be recruited. Patients may be male or female. Patients will be asked to withhold any medication that can influence central nervous system (e.g. levodopa) at least 8 hours prior to the examination. They will also asked to abstain from alcohol for 24 hours before the study.
Sixty normal volunteers ranging from 21-75 will be included. Normal volunteers will be recruited from people who are registered as HMCS Normal Volunteers. Patients would be referred from the HMCS Clinic. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number. Procedures for the fMRI experiment will follow the Standard Operating Procedures of the HMCS Neuroimaging group.
Exclusion Criteria
Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVM's will be excluded.
Patients with progressive neurological disorders other than PD will be excluded.
Patients with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs other than antiparkinsonian medication, will be excluded.
Subjects who have any contraindications to MRI will be excluded from the fMRI part of the study. We will not scan pregnant women because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential prior to functional MRI scan.
Patients not capable of giving informed consent will be excluded.
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
Countries
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Other Identifiers
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02-N-0024
Identifier Type: -
Identifier Source: secondary_id
020024
Identifier Type: -
Identifier Source: org_study_id
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