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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001288
Other study ID # 910134
Secondary ID 91-N-0134
Status Completed
Phase N/A
First received November 3, 1999
Last updated March 3, 2008
Start date May 1991
Est. completion date June 2003

Study information

Verified date June 2003
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 303
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

N/A


Intervention

Drug:
15 O Water

FDG


Locations

Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Albert MS, Butters N, Brandt J. Memory for remote events in alcoholics. J Stud Alcohol. 1980 Nov;41(11):1071-81. — View Citation

Milner B. Interhemispheric differences in the localization of psychological processes in man. Br Med Bull. 1971 Sep;27(3):272-7. Review. — View Citation

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. — View Citation

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