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Multimodal Studies of Language Production and Comprehension in Normal Volunteers and Patients With Neurologically-Based Language Impairments

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Ce qui est collecté

Collecte de données

Qui peut participer

Synucléinopathies+31

+ Troubles d'Articulation

+ Maladies des ganglions de la base

De 18 à 85 ans
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Comment se déroule l'étude

Observationnel
Date de début : avril 1992
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Résumé

Sponsor principalNational Institute on Deafness and Other Communication Disorders (NIDCD)
Dernière mise à jour : 17 décembre 2019
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 28 avril 1992

Date à laquelle le premier participant a commencé l'étude.

Objective The 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. Study Populations We 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. Design We 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. Outcome Measures Outcome 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.

NCT00001308
Sponsor principalNational Institute on Deafness and Other Communication Disorders (NIDCD)
Dernière mise à jour : 17 décembre 2019
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

1163 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 85 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

SynucléinopathiesTroubles d'ArticulationMaladies des ganglions de la baseTroubles MentauxMaladies du cerveauMaladies du système nerveux centralTroubles du langageMaladies laryngéesTroubles du mouvementMaladies et anomalies congénitales, héréditaires et néonatalesMaladies du système nerveuxManifestations NeurologiquesMaladies oto-rhino-laryngologiquesTroubles psychomoteursMaladies des voies respiratoiresSignes et symptômesTroubles de la paroleConditions pathologiques, signes et symptômesTroubles TicsMaladies neurodégénérativesManifestations NeurocomportementalesTroubles hérédo-dégénératifs du système nerveuxTroubles parkinsoniensMaladies Génétiques CongénitalesTroubles du développement neurologiqueAphasieApraxiesTroubles de la communicationDysarthrieSyndrome de TouretteMaladie de ParkinsonBégaiementTroubles de la voixDysphonie

Critères

INCLUSION CRITERIA FOR ALL SUBJECTS: Ages 18 to 85. Ability to provide informed consent. Must be a Native English speaker by age 2 SPECIFIC INCLUSION CRITERIA FOR SELECTED GROUPS OF HEALTHY VOLUNTEERS: Have had training and experience in creative writing Have had training and experience in vocal or instrumental music Have had training and experience in visual arts SPECIFIC INCLUSION CRITERIA FOR POST-STROKE APHASIA SUBJECTS: Had sensorimotor and language deficits following ischemic infarcts. Had stroke at least two weeks ago. SPECIFIC INCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY SUBJECTS: Diagnosis of TBI At least one month post-injury SPECIFIC INCLUSION CRITERIA FOR STUTTERING SUBJECTS: History of developmental stuttering with symptoms of dysfluency presenting before the age of 13 If recovered, history documented by school or medical records. SPECIFIC INCLUSION CRITERIA FOR EPILEPSY SUBJECTS: Ages 18 to 55 years. Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs. Willingness to be considered for surgery Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker. Must have localization-related epilepsy Must be currently enrolled in Protocol 08-N-0161 to participate in this study EXCLUSION CRITERIA FOR ALL SUBJECTS: Past 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 Significant abnormalities on the general physical examination unrelated to the stroke or TBI Unable 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. Subjects who are pregnant are excluded from the PET and MRI tests in this study. Subjects who are lactating are excluded from the PET tests. Subjects who have or are found to have significant visual agnosia. Subjects who cannot provide informed consent. SPECIFIC EXCLUSION CRITERIA FOR POST-STROKE APHASIA SUBJECTS: More than two prior strokes Concurrent diagnoses of neurodegenerative disorders or vascular dementia Comprehension Aphasia Quotient (AQ) of less than 4 on the Western Aphasia Battery (WAB) SPECIFIC EXCLUSION CRITERIA FOR TRAUMATIC BRAIN INJURY SUBJECTS: For military subjects: Positive screen for Acinetobacter baumannii-calcoaceticus complex (ABC) infection or colonization Severe 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. For all subjects: Comprehension AQ of less than 4 on the WAB A diagnosis of PTSD, which is almost always found in TBI subjects recruited from the military, will not disquality TBI subjects from participation. SPECIFIC EXCLUSION CRITERIA FOR STUTTERING SUBJECTS: Structural abnormalities on standard clinical (MPRAGE, T2-weighted) MRI scans studies A diagnosis of anxiety dirorder will not disqualify stuttering subjects from participation SPECIFIC EXCLUSION CRITERIA FOR EPILEPSY SUBJECTS: Claustrophobia or anxiety disorders that could be exacerbated by the MRI Scanner Subjects with neurological disorders, in addition to epilepsy such as, stroke, Parkinson s disease), or who have psychiatric diagnoses (, such as, obsessive-compulsive disorder) Patients on Phenobarbital or chronic Benxodiazepines

Centres d'étude

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Cette étude comporte 1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOuvrir National Institutes of Health Clinical Center, 9000 Rockville Pike dans Google Maps
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