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).
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
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
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / 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
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
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
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
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
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do 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)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .