Viewing Study NCT00039845



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00039845
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2002-06-12

Brief Title: MRI Language Studies in Young Children
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: fMRI Languages Studies In Young Children
Status: COMPLETED
Status Verified Date: 2009-04-20
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will use magnetic resonance imaging MRI to investigate language function in children-that is how language skills such as naming objects understanding spoken language and reading are organized in the brain The study focuses on children between 4 and 7 years old Children 8 to 12 years old and adults will be studied before the younger children to test study paradigms appropriate for pre-literate children The results of this study will help evaluate the usefulness of MRI in identifying language function and location and may improve the treatment of children with seizures

Right-handed native English-speaking adults and children between 4 and 12 years of age may be eligible for this study Candidates will be screened with a routine neurological examination Children will also undergo neuropsychological testing standard tests of language memory perception and attention either at the screening visit or at a later time Parents will fill out a form to identify children with attention deficit and hyperactivity disorders These children will be excluded form the study

All participants will undergo MRI scanning of the brain while performing a task designed to test a language skill such as identifying a picture or listening to or reading a word The MRI detects changes in blood properties in the areas of the brain that perform each task Before the MRI children will be rehearsed for the tests and will have a session in the scanner to know what to expect and feel more at ease during the actual test The time in the MRI machine is usually between 15 and 20 minutes but will be no more than 40 minutes for children 8 to 12 years old and not more than 20 minutes for younger children Children may be requested to have up to five MRI sessions to test different brain functions or confirm findings

Detailed Description: This protocol aims to develop paradigms to identify the neural networks that underlie language processing in preearly literate children These studies are designed to test the hypothesis that language networks are strongly lateralized and regionally specific in children younger than eight The study extends our investigations of paradigm development and language network organization in adults and older children 8-12 to the 4-7 year age group Word reading object naming and auditory comprehension paradigms will be adapted for children 4-7 years old Paradigm stimuli will be devised from pilot data obtained under protocol 01-N-181 Paradigms will be piloted in adults and older children 8-12 years before young child studies 4-7 years and will employ the 15 and 3T scanners Paradigms will be designed to overcome limitations in previous studies monitoring performance in the scanner using 3T and event related designs to improve signal to noise and allow data analysis in relation to task item response and improve motion correction using language neutral control conditions and using paradigms appropriate for pre-literate children Data will be analyzed on an individual basis with AFNI and group analysis with SPM 99 using random effect analysis to identify brain regions associated with task performance These paradigms will be used as language probes for other protocols designed to study the effect of acute and chronic disease states eg stroke and epilepsy on the plasticity of neuronal organization in language networks In order to compare two non-invasive language mapping modes we will perform magnetoencephalography with auditory category and description decision tasks

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
02-N-0223 None None None