NCT00039845

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. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2002

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2002

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2009

Completed
Last Updated

July 2, 2017

Status Verified

April 20, 2009

First QC Date

June 12, 2002

Last Update Submit

June 30, 2017

Conditions

Healthy

Keywords

BrainImagingPediatricsMappingDevelopmentfMRIChildrenLanguageHealthy VolunteerHVNormal Control

Eligibility Criteria

Age4 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.

    PMID: 1635805BACKGROUND

  • Benson RR, FitzGerald DB, LeSueur LL, Kennedy DN, Kwong KK, Buchbinder BR, Davis TL, Weisskoff RM, Talavage TM, Logan WJ, Cosgrove GR, Belliveau JW, Rosen BR. Language dominance determined by whole brain functional MRI in patients with brain lesions. Neurology. 1999 Mar 10;52(4):798-809. doi: 10.1212/wnl.52.4.798.

    PMID: 10078731BACKGROUND

  • Binder JR, Rao SM, Hammeke TA, Frost JA, Bandettini PA, Jesmanowicz A, Hyde JS. Lateralized human brain language systems demonstrated by task subtraction functional magnetic resonance imaging. Arch Neurol. 1995 Jun;52(6):593-601. doi: 10.1001/archneur.1995.00540300067015.

    PMID: 7763208BACKGROUND

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 12, 2002

First Posted

June 13, 2002

Study Start

June 7, 2002

Study Completion

April 20, 2009

Last Updated

July 2, 2017

Record last verified: 2009-04-20

Locations

US(1)