- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07926347
Functional Reorganization and Recovery of the Language and Domain-general Multiple Demand Systems in Aphasia
The objective of this study is to apply state-of-the art brain imaging approaches to evaluate new hypotheses about the contributions of core linguistic vs. domain-general executive systems to language processing and recovery in patients with varying degrees of linguistic impairment. Specifically, the investigators will first characterize the degree to which standard language assessments tax the domain-general Multiple Demand (MD) network (Aim 1). And then systematically investigate the causal contributions of the language and the MD networks to language processing and aphasia recovery in patients of varying severity (Aims 2 and 3).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Swathi Kiran, PhD
- Numéro de téléphone: 617-358-5478
- E-mail: kirans@bu.edu
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Center for Brain Recovery, BU Charles River Campus
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Contact:
- Swathi Kiran, PhD
- Numéro de téléphone: 617-358-5478
- E-mail: brainrec@bu.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- at least 12 weeks post-stroke at time of study enrolment
- medically and neurologically stable (no active seizures for 6 months) and at least wheelchair ambulatory
- premorbid fluency in English
- a family member or caregiver available to assist in study setup and in communicating with study staff
Exclusion Criteria:
- a major, active neurological condition other than stroke, as determined by medical record review
- history of cognitive impairment unrelated to stroke, such as dementia
- history of symptomatic stroke prior to index stroke
- severe uncorrected vision and/or hearing problems likely to impact study participation
- comorbid learning or language disorder diagnosed prior to stroke or as a child
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Immediate treatment
Participants randomized to this arm will receive the intervention immediately after baseline behavioral and neural procedures. |
The Constant Therapy program includes includes 91 therapy exercise programs and participants can practice any of the exercises in the program for 50 hours (60 minutes a day, 5 days a week for 10 weeks). |
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Comparateur actif: Delayed treatment
Participants randomized to this arm will be put on a waitlist for 5 weeks and will then receive the intervention. |
The Constant Therapy program includes includes 91 therapy exercise programs and participants can practice any of the exercises in the program for 50 hours (60 minutes a day, 5 days a week for 10 weeks). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in the Western Aphasia Battery Revised Aphasia Quotient
Délai: Baseline, immediately after the 10-week intervention
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The Western Aphasia Battery Revised Aphasia Quotient (WAB-R-AQ) is a standardized, gold-standard assessment for determining the presence, type, and severity of post-stroke aphasia. The WAB-R measures performance across a variety of expressive and receptive language domains. Weighted performance across four of these domains, namely spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding, yields the WAB-R AQ, a composite score that ranges from 0 to 100, with higher scores indicating better language function. |
Baseline, immediately after the 10-week intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Western Aphasia Battery- Revised Language Quotient (WAB-R LQ)
Délai: Baseline, immediately after the 10-week intervention
|
The WAB-R measures performance across a variety of expressive and receptive language domains and takes approximately 45-60 minutes to administer. Weighted performance across four of these domains - spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding - yields a composite score, the WAB-R Aphasia Quotient (AQ). The WAB-R AQ is an impairment-based metric that reliably indexes aphasia severity across different aphasia subtypes, making it ideal as a metric for studies with heterogenous patient samples as for the current study. In addition to the AQ, Language Quotients (LQ) can be obtained from a full administration of the WAB-R. LQ is a summary score encompassing both spoken and written language abilities. The LQ is scaled from 0 to 100, where higher numbers reflect stronger overall performance across the tested domains. |
Baseline, immediately after the 10-week intervention
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Western Aphasia Battery- Revised Cortical Quotient (WAB-R CQ)
Délai: Baseline, immediately after the 10-week intervention
|
The Cortical Quotient (CQ) is a summary score taking into account all subtests of the WAB-R, including not only spoken and written language but also apraxia, constructional, visuospatial and calculation tasks. Administration of tests to calculate CQ and LQ together take approximately 45 minutes. The CQ is scaled from 0 to 100, where higher numbers reflect stronger overall performance across the tested domains. |
Baseline, immediately after the 10-week intervention
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Boston Naming Test (BNT)
Délai: Baseline, immediately after the 10-week intervention
|
The BNT is one of the most widely used measures of confrontational naming, consisted of 60 line drawings of objects of graded difficulty. It consists of 60 black and white pictures that increase in the order of difficulty (pictures progressively include less frequent words). Scoring comprises accuracy out of 60 items. A point is typically given for items named spontaneously or correctly after a semantic cue (a category or description hint). For healthy, non-brain-damaged adults, average raw scores generally range from 50 to 59 out of 60, depending on age and education level (with normative means clustering around 53 to 55). |
Baseline, immediately after the 10-week intervention
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Pyramids and Palm Trees Test (PPTT)
Délai: Baseline, immediately after the 10-week intervention
|
The PPTT is a visual semantic association task designed to assess semantic memory and the ability to form and retrieve associations between concepts. For each triad, a target stimulus (e.g., a picture or word of a pyramid) is shown at the top, and two choice options (e.g., a palm tree vs. a fir tree) are shown at the bottom. The subject must point to or select the item that semantically matches the target. There are 52 trials. A score of 47 or higher (90% or better: ≥ 47/52) is generally considered normal, indicating no clinically significant semantic memory deficit. A score below 47 (less than 90%) indicates a clinically significant semantic memory impairment. |
Baseline, immediately after the 10-week intervention
|
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Délai: Baseline, immediately after the 10-week intervention
|
The RBANS provides a comprehensive assessment of general cognitive skills, including attention, memory, executive function, and visuospatial processing. The battery consists of 12 short subtests divided across five specific cognitive domains: Immediate Memory: List Learning, Story Memory, Visuospatial/Constructional: Figure Copy, Line Orientation, Language: Picture Naming, Semantic Fluency, Attention: Digit Span, Coding, Delayed Memory: List Recall, List Recognition, Story Recall, Figure Recall. Reported total scores range from 40 to 160, with scores 120 or higher as superior performance. |
Baseline, immediately after the 10-week intervention
|
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Reading Comprehension Battery for Aphasia-2 (RCBA-2)
Délai: Baseline, immediately after the 10-week intervention
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The RCBA-2 provides a comprehensive evaluation of the nature and degree of reading impairments at single word-, sentence- and paragraph-level. Lower total scores indicate more severe acquired reading impairments (alexia) associated with aphasia or brain injury. Total score is 0-100 (10 core subtests), typical range is 97.32, whereas aphasic patients tend to score 18-99. |
Baseline, immediately after the 10-week intervention
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Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Délai: Baseline, immediately after the 10-week intervention
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The SAQOL-39 consists of 39 questions to assess health-related quality of life in individuals with chronic post-stroke aphasia with responses from 1 = Could not do it at all to 5 = No trouble at all. To calculate the scores, the mean (average) value rather than a cumulative sum is calculated and higher means suggest higher quality of life |
Baseline, immediately after the 10-week intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Swathi Kiran, PhD, BU Charles River Campus, Center for Brain Recovery
- Chercheur principal: Evelina Fedorenko, PhD, Massachusetts Institute of Technology
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 8349E
- 1R01DC023439-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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