Brain Blood Flow Studies of Language and Memory

This study has been completed.

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00001288

First received: November 3, 1999

Last updated: March 3, 2008

Last verified: June 2003

History of Changes

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	May 1991
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00001288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Brain Blood Flow Studies of Language and Memory
Official Title ^ICMJE	Cerebral Blood Flow Studies of Language and Memory
Brief Summary	Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow. This study is designed to use positron emission tomography (PET) with radioactive water (H215O) to determine the areas of the brain associated with memory and language. Patients participating in the study will be made up of normal volunteers, patients with epilepsy, and patients with other abnormalities related to the surface of the brain (non-epileptic focal cortical dysfunctions).
Detailed Description	This protocol will use positron emission tomography (PET) with H2015 and functional MRI to examine localization of memory and language in normal control subjects, and patients with localization-related epilepsy.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Cerebrovascular Disorder Epilepsy
Intervention ^ICMJE	Drug: 15 O Water Drug: FDG
Study Group/Cohort (s)	Not Provided
Publications *	Albert MS, Butters N, Brandt J. Memory for remote events in alcoholics. J Stud Alcohol. 1980 Nov;41(11):1071-81. No abstract available. Milner B. Interhemispheric differences in the localization of psychological processes in man. Br Med Bull. 1971 Sep;27(3):272-7. Review. No abstract available. Petersen SE, Fox PT, Posner MI, Mintun M, Raichle ME. Positron emission tomographic studies of the cortical anatomy of single-word processing. Nature. 1988 Feb 18;331(6157):585-9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	303
Completion Date	June 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA: Normal Volunteers: The desired age range is 18 to 55 years. Subjects will have no history of head injury or other neurological disease and must not be taking any medication. Female subjects of childbearing potential will be administered a pregnancy test; these subjects will not be eligible for the study requiring 2 scans. All volunteers will read and sign the consent form. Patients: Patients will be selected from among those referred to the Clinical Epilepsy Section, NINDS for evaluation. EXCLUSION CRITERIA: Patients with evidence of a progressive intracranial process, who are taking any drugs (except AEDs) that might affect the results, or active systemic disease will be excluded.
Gender	Both
Ages	Not Provided
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 Number ^ICMJE	NCT00001288
Other Study ID Numbers ^ICMJE	910134, 91-N-0134
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	June 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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