NCT00004991

Brief Summary

The purpose of this study is to gain a better understanding of the brain's activity and organization in the development of speech disorders. It will compare brain activity in people with normal speech development with those who stutter or who have a phonological disorder (a deficit in how the brain processes speech sounds). Stuttering and phonological disorders emerge during the critical period of speech development between 2.5 and 12 years of age. During this period, the brain is much more adaptable for speech development than it is after puberty. This study will examine how the brain organization for speech production and perception develops normally during the critical period and how the normal pattern is altered when stuttering and phonological disorders become chronic problems, persisting throughout life. Volunteer adults and children with and without speech disorders may participate in this study. Eligibility screening will include a brief neurological and physical examination and tests to determine normal speech or a speech disorder. The speech testing will be videotaped. The subject will speak aloud, describe pictures, recall words or numbers, imitate speech sounds and words, and perform some listening tests. Study participants will undergo magnetic resonance imaging (MRI) to study brain activity. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. During the MRI scan, the subject will perform simple tasks, such as listening to speech or other sounds and saying nonsense words. The procedure should take less than 60 minutes, and usually takes from 20 to 40 minutes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
411

participants targeted

Target at 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2000

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2000

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2009

Completed
Last Updated

July 2, 2017

Status Verified

August 31, 2009

Enrollment Period

9.5 years

First QC Date

March 18, 2000

Last Update Submit

June 30, 2017

Conditions

Keywords

Functional Magnetic Resonance ImagingStutteringSpeech PerceptionSpeech ProductionPhonologyDevelopmentMotor ControlNeural NetworksPhonological Disorders

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To address the 15 hypotheses formulated for this research, several subject groups will be studied. The functional activation patterns of normal right-handed adults will be compared with normally developing right-handed children and adolescents (ages 6-17) during tasks involving speech segmentation (into phonemes) and speech formulation. All will be native speakers of American English without foreign language use in the home. Corresponding subject groups will be adults and children with stuttering or phonological processing disorders who are right-handed native speakers of American English. Our aim will be to determine how brain function for speech perception and production change during completion of the critical period for speech development and how these systems differ in children with disorders of speech control and phonology who continue to have problems during this period.

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)

  • Wise R, Chollet F, Hadar U, Friston K, Hoffner E, Frackowiak R. Distribution of cortical neural networks involved in word comprehension and word retrieval. Brain. 1991 Aug;114 ( Pt 4):1803-17. doi: 10.1093/brain/114.4.1803.

    PMID: 1884179BACKGROUND
  • Klein D, Milner B, Zatorre RJ, Meyer E, Evans AC. The neural substrates underlying word generation: a bilingual functional-imaging study. Proc Natl Acad Sci U S A. 1995 Mar 28;92(7):2899-903. doi: 10.1073/pnas.92.7.2899.

    PMID: 7708745BACKGROUND
  • Muller RA, Behen ME, Rothermel RD, Muzik O, Chakraborty PK, Chugani HT. Brain organization for language in children, adolescents, and adults with left hemisphere lesion: a PET study. Prog Neuropsychopharmacol Biol Psychiatry. 1999 May;23(4):657-68. doi: 10.1016/s0278-5846(99)00024-x.

    PMID: 10390724BACKGROUND

MeSH Terms

Conditions

Articulation DisordersStutteringSpeech Sound Disorder

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 18, 2000

First Posted

March 20, 2000

Study Start

March 14, 2000

Primary Completion

August 31, 2009

Last Updated

July 2, 2017

Record last verified: 2009-08-31

Locations