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

3 de novembro de 2026 atualizado por: 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).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Swathi Kiran, PhD
  • Número de telefone: 617-358-5478
  • E-mail: kirans@bu.edu

Locais de estudo

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Center for Brain Recovery, BU Charles River Campus
        • Contato:
          • Swathi Kiran, PhD
          • Número de telefone: 617-358-5478
          • E-mail: brainrec@bu.edu

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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).

Comparador Ativo: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in the Western Aphasia Battery Revised Aphasia Quotient
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Western Aphasia Battery- Revised Language Quotient (WAB-R LQ)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Swathi Kiran, PhD, BU Charles River Campus, Center for Brain Recovery
  • Investigador principal: Evelina Fedorenko, PhD, Massachusetts Institute of Technology

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de dezembro de 2026

Conclusão Primária (Estimado)

1 de julho de 2031

Conclusão do estudo (Estimado)

1 de julho de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

3 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de novembro de 2026

Primeira postagem (Real)

9 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 8349E
  • 1R01DC023439-01A1 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .