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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00016796
Other study ID # 010181
Secondary ID 01-N-0181
Status Completed
Phase N/A
First received June 2, 2001
Last updated March 3, 2008
Start date May 2001
Est. completion date March 2005

Study information

Verified date March 2005
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study will determine baseline language skills in children 4 to 8 years old. The data will be used to design studies using functional magnetic resonance imaging (fMRI) to identify what areas of the brain in children are involved in understanding language. This information is important for children who require brain surgery to control seizures.

Healthy normal volunteers between the ages of 4 and 8 years who have an IQ of 70 or more; who have no history of neurologic, psychiatric or language disorder; who are performing at or above grade level, and who are native English speakers may be eligible for this study.

Participants will be asked to do the following:

- name pictures or read words that appear on a computer screen

- listen to stories and answer questions about them

- match pictures to a spoken word

The children's responses will be recorded.


Description:

We propose to study normal children to establish baseline data to use to develop novel sets of stimuli for functional imaging paradigms. Tasks using these stimuli will include object naming, sentence comprehension, and single word reading.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility INCLUSION CRITERIA:

Children will be between the ages 4 and 8 are eligible.

EXCLUSION CRITERIA:

Children who meet one of the following criteria are not eligible:

IQ below 70;

History of neurologic or psychiatric disorders;

History of an language disorder;

Performing below grade-level;

Non-native English speaker.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cycowicz YM, Friedman D, Rothstein M, Snodgrass JG. Picture naming by young children: norms for name agreement, familiarity, and visual complexity. J Exp Child Psychol. 1997 May;65(2):171-237. — View Citation

Devinsky O, Perrine K, Llinas R, Luciano DJ, Dogali M. Anterior temporal language areas in patients with early onset of temporal lobe epilepsy. Ann Neurol. 1993 Nov;34(5):727-32. — View Citation

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. — View Citation

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