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Language DisorderNCT00016796

Language Stimuli Screening in Children

An observational study of Language Disorder and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Language Disorder, Healthy
How many people
150 participants
Where
1 siteUnited States
Study dates
May 2001to Mar 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institute of Neurological Disorders and Stroke (NINDS)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read more

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.

Read the detailed 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.

Keywords
Reading, Naming
Medical subject headings
Language Disorders

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2001 (estimated)
  2. Study startMay 2001
  3. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016796
Sponsor's protocol ID
010181
Other IDs
01-N-0181
Status last verified
Mar 2005
First submitted
2 Jun 2001
Last updated
4 Mar 2008
Results posted
No

Publications

  • 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. doi: 10.1212/wnl.48.4.1003.

    PubMed 9109891
  • 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. doi: 10.1002/ana.410340517.

    PubMed 8239568
  • 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. doi: 10.1006/jecp.1996.2356.

    PubMed 9169209

Questions about this trial

What is this clinical trial studying?

An observational study of Language Disorder and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00016796, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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