Skip to main content
OpenTrials
Completed

NCT Number: NCT00039845

MRI Language Studies in Young Children

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.

...

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

This protocol aims to develop paradigms to identify the neural networks that underlie language processing in pre/early 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 1.5 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 (e.g. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

Right handed (Edinburgh Handedness Inventory).

Native English speaker.

Adults and older children (8-12 years) will be recruited to pilot paradigms. Younger children, aged 4-7 years, are the principal subject of the study.

Exclusion criteria

Medical contraindications to MRI procedures (e.g. pacemakers, cochlear devices, surgical clips, etc).

Technical contraindications to MRI procedures (e.g. no braces (distort image data)).

History of neurologic or psychiatric disease or a learning or attentional disorder.

School performance one year below grade level.

CNS active medications.

Pregnancy.

Claustrophobia.

Inability to comply with the protocol.

Volunteers will also be asked if they have a history of dry or irritated eyes and informed this may increase the risk of eye irritation and discomfort in the 3T scanner.

Sponsors and collaborators

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Nih

Registry information

Official study title

fMRI Languages Studies In Young Children

Important dates

Study start
2002
Study completion
2009
First posted
Jun 13, 2002
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.