Studying Automatic Movements in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00063661|
Recruitment Status : Completed
First Posted : July 2, 2003
Last Update Posted : March 4, 2008
|First Submitted Date||July 2, 2003|
|First Posted Date||July 2, 2003|
|Last Update Posted Date||March 4, 2008|
|Study Start Date||June 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Studying Automatic Movements in Patients With Parkinson's Disease|
|Official Title||A Neuroimaging Study of Automatic Movements in Patients With Parkinson's Disease|
Parkinson's disease patients usually have difficulty making automatic movements. Automatic movements are movements people often make without conscious thought.
The purpose of this study is to investigate regions of the brain that affect automatic movements and to understand the movements of Parkinson's patients. Investigators hope this knowledge will lead to better treatment for the disease.
Thirty participants will be enrolled in this study. Each will give a medical history and undergo a brief physical exam. Participants will have two MRI scans, each lasting approximately 1.5 hours. During these scans, they may be asked to move their right or left hands or to remember some letters that they have been shown. Before undergoing the second scan, participants will be asked to practice the tasks until they can perform them correctly.
|Detailed Description||Patients with Parkinson's Disease (PD) are deficient in making automatic movements. The underlying neural correlates of the problem are not understood. In the present study, to investigate the brain activity contributing to this disorder, we will use specially designed dual-task paradigm and the functional magnetic resonance imaging (fMRI) technique. Thirty patients with PD will be asked to perform sequential finger-tapping movement with the right hand; results will be analyzed from 20 patients who achieve automaticity as defined in the study. In addition, we will use a dual-task paradigm to evaluate automaticity by having subjects perform either a distraction task (involving visual memory) or an interference task (tapping with the left hand) simultaneously with the sequential movements. Patients will practice to achieve automaticity. fMRI will be obtained before and after achieving automaticity. By analyzing fMRI results, we will explore the brain regions associated with deficiency of automatic movements in PD patients.|
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Same as current|
|Study Completion Date||May 2005|
|Primary Completion Date||Not Provided|
Thirty patients with PD will be included in the study.
The diagnosis of PD is based on medical history, physical and neurological examinations, response to levodopa or dopaminergic drugs, and laboratory tests and MRI scans to exclude other diseases.
Patients will be assessed with the Unified Parkinson's Disease Rating Scale (UPDRS) and Mini-Mental State Exam (MMSE). Only patients with mild to moderate motor disability (UDRS less than or equal to 40) and without cognitive impairment (MMT score greater than or equal to 25) will be investigated.
Patients will be studied only after their medication has been withdrawn for at least 12 hours.
All subjects participating in the study should have a valid Clinical Center Medical Record Number.
The fMRI experiment will follow the standard operating procedures of the HMCS Neuroimaging Group.
Subjects with psychiatric disorders or severe motor disabilities will be excluded.
Subjects with pacemakers, cardiac or neural defibrillators, intracranial aneurysm clips, intraorbital metallic structures, insulin pumps, cochlear implants, and other metallic objects will not be scanned.
Women who are pregnant are excluded from MRI because the safety of the fetus in the presence of high magnetic fields is not established. Therefore, all women of childbearing potential will have a pregnancy test performed, which must be negative, before proceeding.
Subjects under age 18 will be excluded.
|Ages||Child, Adult, Older Adult|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||030236
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2005|