Mapping the Areas of the Brain Associated With Language in Children With Epilepsy - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	August 1993
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Mapping the Areas of the Brain Associated With Language in Children With Epilepsy
Official Title ^ICMJE	MRI-Based Functional Language Mapping in Children With Epilepsy
Brief Summary	Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for locating the areas of the brain associated with language in children with epilepsy. 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. Patients participating in the study will be asked to perform tasks designed to test language skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood flow.
Detailed Description	We propose to study the feasibility of utilizing MRI to perform functional mapping of language cortex in children with epilepsy. We will use 1.5 Tesla MRI to study cerebral blood flow and tissue oxygenation during cognitive activation tasks derived from previous adult studies.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Epilepsy Seizures
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Hertz-Pannier L, Gaillard WD, Mott SH, Cuenod CA, Bookheimer SY, Weinstein S, Conry J, Papero PH, Schiff SJ, Le Bihan D, Theodore WH. Noninvasive assessment of language dominance in children and adolescents with functional MRI: a preliminary study. Neurology. 1997 Apr;48(4):1003-12. Bookheimer SY, Zeffiro TA, Blaxton T, Malow BA, Gaillard WD, Sato S, Kufta C, Fedio P, Theodore WH. A direct comparison of PET activation and electrocortical stimulation mapping for language localization. Neurology. 1997 Apr;48(4):1056-65. Malow BA, Blaxton TA, Sato S, Bookheimer SY, Kufta CV, Figlozzi CM, Theodore WH. Cortical stimulation elicits regional distinctions in auditory and visual naming. Epilepsia. 1996 Mar;37(3):245-52.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	230
Completion Date	September 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Children aged 5-17 years. Partial epilepsy (localized). Ability to cooperate with task paradigms (IQ greater than 65). No cardiac pacemakers, cochlear implants, shrapnel, vascular clips, braces, or claustrophobia. No one with inability to cooperate with task paradigms.
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	NCT00001366
Responsible Party
Study ID Numbers ^ICMJE	930191, 93-N-0191
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	September 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP