Developmental Articulation DisorderNCT00004991
Study of Brain Activity During Speech Production and Speech Perception
An observational study of Developmental Articulation Disorder and Stuttering, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Articulation Disorder, Stuttering
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2000to 31 Aug 2009
- 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 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular implant or foreign body (e.g. metal shavings or splinters); insulin pump; shrapnel, bullet or shot wound; artificial heart valve; tattooed makeup; prostheses of ferromagnetic material; surgical metal clips in the brain, eye or on blood vessels; implanted drug infusion device. The LSS otolaryngologist, Pamela Kearney, M.D., or LSS nurse practitioner Patti Henshel, C.R.N.P., will screen participants with the NMR Center Safety Screening Questionnaire, which also includes additional items such as intraventricular shunts, transdermal medication patches, wire sutures, bone/joint pins, screws, nails, plates, and body piercings. Dr. Kearney or Ms. Henshel will approve or disapprove participation in the study based on her judgement of the MR compatibility of these items, using published guides including Shellock \& Kanal (1994) and Shellock (2001). Other exclusion criteria are claustrophobia, pregnancy (as determined by pregnancy testing at NIH's Clinical Center on the day of scanning); aphasia or dysarthria, language and/or cognitive functioning lower than 2 standard deviations below the age-adjusted mean value on screening tests, speech reception thresholds greater than dB; non-native American English speech development; developmental exposure to a language other than English in the home, and medications that affect central nervous system function at time of fMRI scanning. If a potential participant elects to withdraw from medications, this must be done under the care of the participant's own physician prior to participation in this protocol. Medication withdrawal is not part of this study.
- Additional exclusion criteria for developmental stuttering only include: language and/or cognitive functioning lower than 1 standard deviation below the age-adjusted mean value on screening tests, left-handedness on the Edinburgh handedness questionnaire; movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), brain tumors, history of traumatic brain injury with loss of consciousness, genetic diseases of the CNS (e.g., chromosomal diseases, metabolic disorders, diffuse sclerosis), chronic infections of the nervous system (e.g., bacterial, vial, parasitic, fungal and yeast), ataxias (inherited and acquired), myopathies (e.g., progressive muscular dystrophies, familial periodic paralysis, congenital disorders of muscle, myoglobinuria, polymyositis), disorders of the neuromuscular junction (e.g., myasthenia gravis), demyelinating diseases (e.g., multiple sclerosis, central pontine myelinolysis), other brain abnormalities, schizophrenia, alcoholism, long-lasting drug dependence, major and/or bipolar depression, obsessive-compulsive disorder, vocal fold paralysis or paresis, joint abnormality, or neoplasm, and history of swallowing disorders, airway obstruction.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Brain Activation During Developmental Speech Production and Speech Perception
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.
Read more
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.
Read the detailed description
This is a study of two developmental speech production disorders, which emerge during the critical period of speech development between 2.5 and 12 years of age. During this critical period there is considerably greater brain plasticity for speech functioning which disappears following puberty. Our purpose is to determine how normal brain organization for speech production and perception develops during the critical period and how this normal pattern is altered when stuttering and phonological disorders become chronic problems, persisting throughout the life span. Functional MRI and magnetoencephalography (MEG) are non-invasive methodologies suitable for research in these disorders in children. New methodologies using fMRI and MEG provide the first opportunity for the study of speech production both in normally developing children as well as children and adults with stuttering and/or phonological disorders. Our hypothesis is that, with development, the brain organization for speech production becomes less distributed involving fewer brain regions, and that phonological processing mechanisms become lateralized to the left hemisphere during the critical period of speech development. This research will address whether the brain regions involved in speech are more diffuse and less selective in persons who develop chronic stuttering and phonological disorders, leading to a less efficient dynamic system for speech production.
- Conditions
- Developmental Articulation Disorder, Stuttering
- Keywords
- Functional Magnetic Resonance Imaging, Stuttering, Speech Perception, Speech Production, Phonology, Development, Motor Control, Neural Networks, Phonological Disorders
- Medical subject headings
- Articulation Disorders, Stuttering, Speech Sound Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2000 (estimated)
- Study start14 Mar 2000
- Primary completion31 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental Articulation DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 411 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004991
- Sponsor's protocol ID
- 000095
- Other IDs
- 00-N-0095
- Status last verified
- 31 Aug 2009
- First submitted
- 18 Mar 2000
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 1884179Klein 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.
PubMed 7708745Muller 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.
PubMed 10390724
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activation During Developmental Speech Production and Speech Perception
- ClinicalTrials.gov ID
- NCT00004991
- Acronym / sponsor ID
- 000095
- Conditions
- Developmental Articulation Disorder, Stuttering
- Keywords
- Functional Magnetic Resonance Imaging, Stuttering, Speech Perception, Speech Production, Phonology, Development, Motor Control, Neural Networks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Mar 2000
- Primary completion
- 31 Aug 2009 (actual)
- First posted
- 20 Mar 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study of two developmental speech production disorders, which emerge during the critical period of speech development between 2.5 and 12 years of age. During this critical period there is considerably greater brain plasticity for speech functioning which disappears following puberty. Our purpose is to determine how normal brain organization for speech production and perception develops during the critical period and how this normal pattern is altered when stuttering and phonological disorders become chronic problems, persisting throughout the life span. Functional MRI and magnetoencephalography (MEG) are non-invasive methodologies suitable for research in these disorders in children. New methodologies using fMRI and MEG provide the first opportunity for the study of speech production both in normally developing children as well as children and adults with stuttering and/or phonological disorders. Our hypothesis is that, with development, the brain organization for speech production becomes less distributed involving fewer brain regions, and that phonological processing mechanisms become lateralized to the left hemisphere during the critical period of speech development. This research will address whether the brain regions involved in speech are more diffuse and less selective in persons who develop chronic stuttering and phonological disorders, leading to a less efficient dynamic system for speech production.
Study design
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular implant or foreign body (e.g. metal shavings or splinters); insulin pump; shrapnel, bullet or shot wound; artificial heart valve; tattooed makeup; prostheses of ferromagnetic material; surgical metal clips in the brain, eye or on blood vessels; implanted drug infusion device. The LSS otolaryngologist, Pamela Kearney, M.D., or LSS nurse practitioner Patti Henshel, C.R.N.P., will screen participants with the NMR Center Safety Screening Questionnaire, which also includes additional items such as intraventricular shunts, transdermal medication patches, wire sutures, bone/joint pins, screws, nails, plates, and body piercings. Dr. Kearney or Ms. Henshel will approve or disapprove participation in the study based on her judgement of the MR compatibility of these items, using published guides including Shellock \& Kanal (1994) and Shellock (2001). Other exclusion criteria are claustrophobia, pregnancy (as determined by pregnancy testing at NIH's Clinical Center on the day of scanning); aphasia or dysarthria, language and/or cognitive functioning lower than 2 standard deviations below the age-adjusted mean value on screening tests, speech reception thresholds greater than dB; non-native American English speech development; developmental exposure to a language other than English in the home, and medications that affect central nervous system function at time of fMRI scanning. If a potential participant elects to withdraw from medications, this must be done under the care of the participant's own physician prior to participation in this protocol. Medication withdrawal is not part of this study.
- Additional exclusion criteria for developmental stuttering only include: language and/or cognitive functioning lower than 1 standard deviation below the age-adjusted mean value on screening tests, left-handedness on the Edinburgh handedness questionnaire; movement disorders (e.g., Huntington disease, chorea, myoclonus, Gilles de la Tourette syndrome, Parkinson's disease, progressive supranuclear palsy, and neuroleptic-induced syndromes), brain tumors, history of traumatic brain injury with loss of consciousness, genetic diseases of the CNS (e.g., chromosomal diseases, metabolic disorders, diffuse sclerosis), chronic infections of the nervous system (e.g., bacterial, vial, parasitic, fungal and yeast), ataxias (inherited and acquired), myopathies (e.g., progressive muscular dystrophies, familial periodic paralysis, congenital disorders of muscle, myoglobinuria, polymyositis), disorders of the neuromuscular junction (e.g., myasthenia gravis), demyelinating diseases (e.g., multiple sclerosis, central pontine myelinolysis), other brain abnormalities, schizophrenia, alcoholism, long-lasting drug dependence, major and/or bipolar depression, obsessive-compulsive disorder, vocal fold paralysis or paresis, joint abnormality, or neoplasm, and history of swallowing disorders, airway obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1884179Wise 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.
- Background: PubMed 7708745Klein 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.
- Background: PubMed 10390724Muller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Articulation Disorder and Stuttering, 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 2 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 2 Jul 2017. 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 NCT00004991, 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 2 Jul 2017.