Completed

Brain Activation During Developmental Speech Production and Speech Perception

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Who is being recruted

Mental Disorders+10

+ Communication Disorders

+ Language Disorders

From 6 to 65 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: March 2000
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 14, 2000

Actual date on which the first participant was enrolled.

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.

NCT00004991
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

411 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersCommunication DisordersLanguage DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsSpeech DisordersPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurodevelopmental DisordersArticulation DisordersStutteringSpeech Sound Disorder

Criteria

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center