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Functional Reorganization and Recovery of the Language and Domain-general Multiple Demand Systems in Aphasia

3 novembre 2026 mis à jour par: Boston University Charles River Campus

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

Pas encore de recrutement

Les conditions

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Swathi Kiran, PhD
  • Numéro de téléphone: 617-358-5478
  • E-mail: kirans@bu.edu

Lieux d'étude

    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Center for Brain Recovery, BU Charles River Campus
        • Contact:
          • Swathi Kiran, PhD
          • Numéro de téléphone: 617-358-5478
          • E-mail: brainrec@bu.edu

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
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).

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
Change in the Western Aphasia Battery Revised Aphasia Quotient
Délai: Baseline, immediately after the 10-week intervention

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
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
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
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
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
Reading Comprehension Battery for Aphasia-2 (RCBA-2)
Délai: Baseline, immediately after the 10-week intervention

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
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Délai: Baseline, immediately after the 10-week intervention

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 décembre 2026

Achèvement primaire (Estimé)

1 juillet 2031

Achèvement de l'étude (Estimé)

1 juillet 2032

Dates d'inscription aux études

Première soumission

3 novembre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

9 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

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Informations sur les médicaments et les dispositifs, documents d'étude

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