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).
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Swathi Kiran, PhD
- Telefonní číslo: 617-358-5478
- E-mail: kirans@bu.edu
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Center for Brain Recovery, BU Charles River Campus
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Kontakt:
- Swathi Kiran, PhD
- Telefonní číslo: 617-358-5478
- E-mail: brainrec@bu.edu
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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). |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in the Western Aphasia Battery Revised Aphasia Quotient
Časové okno: 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
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Western Aphasia Battery- Revised Language Quotient (WAB-R LQ)
Časové okno: Baseline, immediately after the 10-week intervention
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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)
Časové okno: 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)
Časové okno: Baseline, immediately after the 10-week intervention
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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)
Časové okno: Baseline, immediately after the 10-week intervention
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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)
Časové okno: Baseline, immediately after the 10-week intervention
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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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Swathi Kiran, PhD, BU Charles River Campus, Center for Brain Recovery
- Vrchní vyšetřovatel: Evelina Fedorenko, PhD, Massachusetts Institute of Technology
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 8349E
- 1R01DC023439-01A1 (Grant/smlouva NIH USA)
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Plánujete sdílet data jednotlivých účastníků (IPD)?
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