MRI Language Studies in Young Children

June 30, 2017 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

fMRI Languages 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.

...

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 7, 2002

Study Completion

April 20, 2009

Study Registration Dates

First Submitted

June 12, 2002

First Submitted That Met QC Criteria

June 12, 2002

First Posted (Estimate)

June 13, 2002

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

April 20, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 020223
  • 02-N-0223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe