Nctid:
NCT00001308
Payload:
{"FullStudy"=>{"Rank"=>474038, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 06, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014832", "ConditionMeshTerm"=>"Voice Disorders"}, {"ConditionMeshId"=>"D000005879", "ConditionMeshTerm"=>"Tourette Syndrome"}, {"ConditionMeshId"=>"D000013342", "ConditionMeshTerm"=>"Stuttering"}, {"ConditionMeshId"=>"D000003147", "ConditionMeshTerm"=>"Communication Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001480", "ConditionAncestorTerm"=>"Basal Ganglia Diseases"}, {"ConditionAncestorId"=>"D000001927", "ConditionAncestorTerm"=>"Brain Diseases"}, {"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000013981", "ConditionAncestorTerm"=>"Tic Disorders"}, {"ConditionAncestorId"=>"D000009069", "ConditionAncestorTerm"=>"Movement Disorders"}, {"ConditionAncestorId"=>"D000020271", "ConditionAncestorTerm"=>"Heredodegenerative Disorders, Nervous System"}, {"ConditionAncestorId"=>"D000019636", "ConditionAncestorTerm"=>"Neurodegenerative Diseases"}, {"ConditionAncestorId"=>"D000030342", "ConditionAncestorTerm"=>"Genetic Diseases, Inborn"}, {"ConditionAncestorId"=>"D000065886", "ConditionAncestorTerm"=>"Neurodevelopmental Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000013064", "ConditionAncestorTerm"=>"Speech Disorders"}, {"ConditionAncestorId"=>"D000007806", "ConditionAncestorTerm"=>"Language Disorders"}, {"ConditionAncestorId"=>"D000019954", "ConditionAncestorTerm"=>"Neurobehavioral Manifestations"}, {"ConditionAncestorId"=>"D000009461", "ConditionAncestorTerm"=>"Neurologic Manifestations"}, {"ConditionAncestorId"=>"D000007818", "ConditionAncestorTerm"=>"Laryngeal Diseases"}, {"ConditionAncestorId"=>"D000012140", "ConditionAncestorTerm"=>"Respiratory Tract Diseases"}, {"ConditionAncestorId"=>"D000010038", "ConditionAncestorTerm"=>"Otorhinolaryngologic Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12903", "ConditionBrowseLeafName"=>"Parkinson Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10513", "ConditionBrowseLeafName"=>"Language Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27748", "ConditionBrowseLeafName"=>"Dysphonia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9438", "ConditionBrowseLeafName"=>"Hoarseness", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4042", "ConditionBrowseLeafName"=>"Aphasia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17265", "ConditionBrowseLeafName"=>"Voice Disorders", "ConditionBrowseLeafAsFound"=>"Voice Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M8681", "ConditionBrowseLeafName"=>"Tourette Syndrome", "ConditionBrowseLeafAsFound"=>"Tourette Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6064", "ConditionBrowseLeafName"=>"Communication Disorders", "ConditionBrowseLeafAsFound"=>"Communication Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M7265", "ConditionBrowseLeafName"=>"Dysarthria", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15822", "ConditionBrowseLeafName"=>"Stuttering", "ConditionBrowseLeafAsFound"=>"Stuttering", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4074", "ConditionBrowseLeafName"=>"Apraxias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M25293", "ConditionBrowseLeafName"=>"Ganglion Cysts", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16048", "ConditionBrowseLeafName"=>"Synovial Cyst", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4464", "ConditionBrowseLeafName"=>"Basal Ganglia Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4894", "ConditionBrowseLeafName"=>"Brain Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16429", "ConditionBrowseLeafName"=>"Tic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21822", "ConditionBrowseLeafName"=>"Tics", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11719", "ConditionBrowseLeafName"=>"Movement Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21782", "ConditionBrowseLeafName"=>"Heredodegenerative Disorders, Nervous System", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21248", "ConditionBrowseLeafName"=>"Neurodegenerative Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M23376", "ConditionBrowseLeafName"=>"Genetic Diseases, Inborn", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M30334", "ConditionBrowseLeafName"=>"Neurodevelopmental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15554", "ConditionBrowseLeafName"=>"Speech Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21516", "ConditionBrowseLeafName"=>"Neurobehavioral Manifestations", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12094", "ConditionBrowseLeafName"=>"Neurologic Manifestations", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10525", "ConditionBrowseLeafName"=>"Laryngeal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14667", "ConditionBrowseLeafName"=>"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12651", "ConditionBrowseLeafName"=>"Otorhinolaryngologic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5289", "ConditionBrowseLeafName"=>"Spasmodic Dysphonia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T465", "ConditionBrowseLeafName"=>"Apraxia", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}, {"ConditionBrowseBranchName"=>"Ear, Nose, and Throat Diseases", "ConditionBrowseBranchAbbrev"=>"BC09"}, {"ConditionBrowseBranchName"=>"Diseases and Abnormalities at or Before Birth", "ConditionBrowseBranchAbbrev"=>"BC16"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"1163"}}, "StatusModule"=>{"OverallStatus"=>"Terminated", "StartDateStruct"=>{"StartDate"=>"April 28, 1992"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 6, 2016", "CompletionDateStruct"=>{"CompletionDate"=>"October 6, 2016"}, "LastUpdateSubmitDate"=>"December 14, 2019", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 17, 2019", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Stuttering", "Tourette's Syndrome", "Spasmodic Dysphonia", "Dysarthria", "Parkinson's Disease", "Verbal Dyspraxia", "Aphasia", "Speech", "Motor Control"]}, "ConditionList"=>{"Condition"=>["Communication Disorder", "Healthy", "Stuttering", "Tourette Syndrome", "Voice Disorder"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"3085570", "ReferenceType"=>"background", "ReferenceCitation"=>"Alexander GE, DeLong MR, Strick PL. Parallel organization of functionally segregated circuits linking basal ganglia and cortex. Annu Rev Neurosci. 1986;9:357-81. doi: 10.1146/annurev.ne.09.030186.002041. No abstract available."}, {"ReferencePMID"=>"5035315", "ReferenceType"=>"background", "ReferenceCitation"=>"Andrews G, Quinn PT, Sorby WA. Stuttering: an investigation into cerebral dominance for speech. J Neurol Neurosurg Psychiatry. 1972 Jun;35(3):414-8. doi: 10.1136/jnnp.35.3.414."}, {"ReferencePMID"=>"3498529", "ReferenceType"=>"background", "ReferenceCitation"=>"Bartlett EJ, Brown JW, Wolf AP, Brodie JD. Correlations between glucose metabolic rates in brain regions of healthy male adults at rest and during language stimulation. Brain Lang. 1987 Sep;32(1):1-18. doi: 10.1016/0093-934x(87)90115-5."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal biochemical and metabolic processes of the central nervous system of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. Radioactive water H215O in PET scans permits good visualization of areas of the brain related to speech.\n\nMost of the PET scan studies conducted have concentrated on learning about how language is formed and decoded. Few studies have been conducted on speech production. This study aims to use radioactive water (H215O) and Positron Emission Tomography (PET scan) to measure blood flow to different areas of the brain in order to better understand the mechanisms involved in speech motor control.\n\nWhen a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive chemicals (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.\n\nResearchers will ask patients to perform tasks that will affect speech, voice, and language. At the same time patients will undergo a PET scan. The tasks are designed to help researchers observe the blood flow to brain areas associated with voicebox (laryngeal) functions, movement of muscles in the jaw, tongue, and mouth, and other aspects of motor speech.\n\nSpecial studies will be conducted to evaluate how certain therapies and tasks can draw out symptoms in illnesses in which speech and language are affected. Results of these tests will be used in other studies to evaluate the neurologic mechanisms of diseases like Tourette's syndrome and parkinson's disease.<TAB>", "DetailedDescription"=>"Objective\n\nThe primary objective of this protocol is to use multimodal neuroimaging combining complementary electrophysiological and hemodynamic methods to characterize brain-language relationships in healthy subjects and those with neurological disorders that affect speech and language. A secondary objective is to utilize these findings to develop evaluation measures for future treatment studies.\n\nStudy Populations\n\nWe will focus on four neurological disorders that affect language processing post-stroke aphasia, traumatic brain injury, epilepsy and developmental stuttering. Each constitutes a significant clinical problem central to the NIDCD s mission. These disorders can impair language at several levels - from its elementary perceptual and motor features, the peripheral building blocks of language, to higher levels of language formulation, including word, sentence and narrative processing.\n\nDesign\n\nWe will utilize a set of tasks designed to evaluate language at the levels at which clinical pathology emerges. We will combine hemodynamic (functional MRI) and electrophysiological (EEG, MEG) modalities to capitalize on the superior spatial resolution of the former and temporal resolution of the latter methods. Whenever possible the same task paradigms are used with both techniques. We will conduct crosssectional sub-studies, addressing specific questions in each of the disorders of interest; we will also conduct longitudinal sub-studies of recovery and neuroplastic reorganization in post-stroke aphasia.\n\nOutcome Measures\n\nOutcome measures include speech-language and psychological tests, measures of behavioral performance during scanning and corresponding MRI, EEG and MEG data. Relationships between these datasets will be evaluated using statistical analytic packages."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"85 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"INCLUSION CRITERIA FOR ALL SUBJECTS:\n\nAges 18 to 85.\n\nAbility to provide informed consent.\n\nMust be a Native English speaker by age 2\n\nSPECIFIC INCLUSION CRITERIA FOR SELECTED GROUPS OF HEALTHY VOLUNTEERS:\n\nHave had training and experience in creative writing\n\nHave had training and experience in vocal or instrumental music\n\nHave had training and experience in visual arts\n\nSPECIFIC INCLUSION CRITERIA FOR POST-STROKE APHASIA SUBJECTS:\n\nHad sensorimotor and language deficits following ischemic infarcts.\n\nHad stroke at least two weeks ago.\n\nSPECIFIC INCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY SUBJECTS:\n\nDiagnosis of TBI\n\nAt least one month post-injury\n\nSPECIFIC INCLUSION CRITERIA FOR STUTTERING SUBJECTS:\n\nHistory of developmental stuttering with symptoms of dysfluency presenting before the age of 13\n\nIf recovered, history documented by school or medical records.\n\nSPECIFIC INCLUSION CRITERIA FOR EPILEPSY SUBJECTS:\n\nAges 18 to 55 years.\n\nFailure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs.\n\nWillingness to be considered for surgery\n\nFluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker.\n\nMust have localization-related epilepsy\n\nMust be currently enrolled in Protocol 08-N-0161 to participate in this study\n\nEXCLUSION CRITERIA FOR ALL SUBJECTS:\n\nPast or present major medical or psychiatric illnesses (DSM-IV criteria) except Post Traumatic Stress Disorder (PTSD) in TBI subjects an anxiety disorder in stuttering subjects\n\nSignificant abnormalities on the general physical examination unrelated to the stroke or TBI\n\nUnable to undergo MRI studies due to pacemakers, aneurysm clips, cochlear implants, shrapnel fragments or a significant history of exposure to small metallic objects which might have become lodged in the tissues of the head or neck or who require hearing aids.\n\nSubjects who are pregnant are excluded from the PET and MRI tests in this study.\n\nSubjects who are lactating are excluded from the PET tests.\n\nSubjects who have or are found to have significant visual agnosia.\n\nSubjects who cannot provide informed consent.\n\nSPECIFIC EXCLUSION CRITERIA FOR POST-STROKE APHASIA SUBJECTS:\n\nMore than two prior strokes\n\nConcurrent diagnoses of neurodegenerative disorders or vascular dementia\n\nComprehension Aphasia Quotient (AQ) of less than 4 on the Western Aphasia Battery (WAB)\n\nSPECIFIC EXCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY SUBJECTS:\n\nFor military subjects: Positive screen for Acinetobacter baumannii-calcoaceticus complex (ABC) infection or colonization\n\nSevere cognitive impairments as evidenced by scores of less than 7 on the Rancho Los Amigos Scale of Cognitive Functioning and/or less than 76 on the Galveston Orientation and Amnesia Test.\n\nFor all subjects: Comprehension AQ of less than 4 on the WAB\n\nA diagnosis of PTSD, which is almost always found in TBI subjects recruited from the military, will not disquality TBI subjects from participation.\n\nSPECIFIC EXCLUSION CRITERIA FOR STUTTERING SUBJECTS:\n\nStructural abnormalities on standard clinical (MPRAGE, T2-weighted) MRI scans studies\n\nA diagnosis of anxiety dirorder will not disqualify stuttering subjects from participation\n\nSPECIFIC EXCLUSION CRITERIA FOR EPILEPSY SUBJECTS:\n\nClaustrophobia or anxiety disorders that could be exacerbated by the MRI Scanner\n\nSubjects with neurological disorders, in addition to epilepsy such as, stroke, Parkinson s disease), or who have psychiatric diagnoses (, such as, obsessive-compulsive disorder)\n\nPatients on Phenobarbital or chronic Benxodiazepines"}, "IdentificationModule"=>{"NCTId"=>"NCT00001308", "BriefTitle"=>"Central Mechanisms in Speech Motor Control Studied With H215O PET", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Multimodal Studies of Language Production and Comprehension in Normal Volunteers and Patients With Neurologically-Based Language Impairments", "OrgStudyIdInfo"=>{"OrgStudyId"=>"920178"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"92-DC-0178"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Allen R Braun, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)", "LeadSponsorClass"=>"NIH"}}}}}}