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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 17, 2001 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | December 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00028197 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Comparison of Externally and Self-Initiated Movements |
| Official Title ICMJE | Comparison of Externally and Self-Initiated Movements |
| Brief Summary | This study will use magnetic resonance imaging (MRI) to investigate how the brain controls voluntary movements triggered by an external stimulus or self-initiated. Registered HCMS healthy normal volunteers may participate. They will complete a questionnaire and will have a medical history and brief physical examination. The study consists of two parts: 1) body movement training and 2) magnetic resonance imaging, as follows: Part 1 - Body movement training Participants will train to do three different body movements involving the hands and feet. The movements will either be self-initiated or in response to a stimulus, such as a visual or auditory trigger. Part 2 - Magnetic resonance imaging Participants will do one or more of the trained movements, with or without a triggering stimulus, during MRI scanning. MRI is a diagnostic procedure that uses a magnetic field and radio waves to produce images of brain structure and activity. For the procedure, the subject lies on a stretcher that is moved into the scanner-a cylinder containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises that occur with electrical switching of radio frequency circuits. Scanning time varies from 20 minutes to 2 hours, with most examinations lasting 1 to 1-1/2 hours. The subject can communicate with the staff person conducting the test at all times during the scan. A device compatible with magnetic resonance will be used to record the participant's body movements. The participant may be asked to push buttons of the device during the tasks. |
| Detailed Description | Voluntary movements are divided into two categories, one is externally triggered movement and the other is self-initiated movement. The underlying neural mechanisms in each movement have been investigated, but they are not fully understood. The present study is aimed to understand the neural mechanisms, especially aimed to find out the commonly devoted brain area for the categorized movements. By obtaining functional magnetic resonance imaging (fMRI) signals during triggered movement tasks designed from 3 input triggers of different modalities (visual, auditory, and somatosensory) and 3 output movements of different body parts (right hand, left hand, and right foot), we will determine the brain regions specially devoted for each input or output, and commonly devoted for triggered movements. By obtaining fMRI signals during spontaneous voluntary movement tasks designed from 3 output movements of the same body parts, we will determine the brain regions specially devoted for specific execution and commonly devoted for the voluntarily chosen movements. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Healthy |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 55 |
| Completion Date | November 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | INCLUSION CRITERIA: Normal volunteers will be included. Normal volunteers will be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number. EXCLUSION CRITERIA: 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. If the result from a urine pregnancy test is not available for some reason, a medical doctor will judge based on the proper information prior to the scanning. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00028197 |
| Responsible Party | |
| Study ID Numbers ICMJE | 020068, 02-N-0068 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | November 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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