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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | September 24, 2009 | ||||||||
| Start Date ICMJE | July 1993 | ||||||||
| Estimated Primary Completion Date | July 1996 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Primary endpoints will be changes in peripheral blood counts (platelets, absolute neutrophil count, reticulocyte count, hemoglobin). | ||||||||
| Change History | Complete list of historical versions of study NCT00001360 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
Secondary endpoints (in transfusion-dependent patients) include improvements in the transfusion requirements, duration of response, late effects of treatment, relapse and survival. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Studies of Blood Flow to the Brain During Thought | ||||||||
| Official Title ICMJE | Regional Cerebral Blood Flow Studies of Object Perception, Identification, Localization, and Memory | ||||||||
| Brief Summary | The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks. This study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visual perception, visual recognition, and memory. |
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| Detailed Description | Magnetic resonance imaging will be used to measure hemodynamic changes in healthy human subjects engaged in performing cognitive tasks. Specific questions concerning the location of the neural systems that mediate perceptual and semantic representations of objects and the spatial coordinate systems used for object localization will be addressed. The studies proposed here will be conducted only on normal adult men and women to examine the functional organization of the intact human brain. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| 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 | Recruiting | ||||||||
| Enrollment ICMJE | 1750 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | July 1996 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Normal adults, with at least a high school education, aged 18 to 65 years, will be recruited to participate in the study. EXCLUSION CRITERIA: Subjects will be excluded if they have evidence of, or a history of, learning disability, psychiatric condition, head trauma, seizures or other neurological condition, alcoholism or substance abuse, hypertension, or cardiovascular disease. We will also exclude subjects with vision and/or hearing problems severe enough to interfere with testing. Females with a positive pregnancy test will be excluded from neuroimaging studies. All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Those whose history is suggestive of such a problem will be excluded. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded because of possible risks during MRI scanning. |
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001360 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 930170, 93-M-0170 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | April 2009 | ||||||||
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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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