Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: Pilot Study of Multidimensional Effects

Официальное название

Combining Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: a Pilot Study of Multidimensional Effects

Обзор

The goal of this clinical trial is to measure the effects of a speech therapy protocol combining anomia therapy and executive function training on naming and discourse in people with chronic aphasia, and to study the related brain changes. The main questions it aims to answer are: * Does the protocol improve naming skills ? * Do the improvements observed transfer to discourse abilities ? * Are there any brain changes induced by this protocol ? Researchers will compare anomia therapy alone to anomia therapy + executive function training to see if the latter works better. Participants will: * Have a whole language assessment and a Magnetic Resonance Imaging (MRI) scan in the hospital before and after the protocol * Receive 18 sessions of the protocol, 3 times a week during 6 weeks, in the hospital * Have several naming assessments during the protocol

Вмешательства

• Поведенческое Anomia therapy: semantic feature analysis and phonological components analysis;
  After the initial assessment + functional Magnetic Resonance Imaging (fMRI), participants will first receive their usual speech therapy rehabilitation for 10 to 15 sessions (baseline phase), and then enter the experimental phase: 18 sessions (3 per week) of either anomia therapy alone or anomia therapy + executive function training, according to the arm they were assigned to. All sessions will last 45 minutes. Naming skills will be repeatedly measured during both phases. A second assessment of l
• Поведенческое Executive function training: computerized equipment
  Executive function training will be conducted by means of a computerized material specifically designed for the study, consisting of verbal and nonverbal exercises targeting, always in the same order, inhibition, shifting, working memory and planning functions, with a gradient of difficulty. Training will always be done at the beginning of the session, during 20 minutes, before anomia therapy.

Первичные конечные точки

• Change in repeated measures of naming scores [Срок оценки: Every 2 or 3 sessions during the baseline phase (3 sessions per week during 3,5 to 5 weeks) and during the experimental phase (3 sessions per week during 6 weeks)]

Вторичные конечные точки (8)

• Comparison of pre and post intervention control naming scores for each group (arm A / arm B) and between groups. [Срок оценки: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, 6 weeks after: just after the intervention, and 4 weeks after]
• Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Productivity (number of words produced / minute) [Срок оценки: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention]
• Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Informativity (% of correct information units) [Срок оценки: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention]
• Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Lexical diversity (type-token ratio) [Срок оценки: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention]
• Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Syntactic structure (Predicate Argument Structure) [Срок оценки: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention]
• Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Efficience (Main Concept Analysis) [Срок оценки: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention]
• MRI: Quantitative analyses [Срок оценки: Before the baseline and just after the intervention: 9,5 to 11 weeks after]
• MRI: Qualitative analyses [Срок оценки: Before the baseline and just after the intervention: 9,5 to 11 weeks after]

Критерии участия

Критерии включения

• Adult (18-80 years old) with post-stroke aphasia (> 6 months post-stroke)
• Participant or legal representative able to understand the aims of the study
• Participant or legal representative who have signed an informed consent form

Критерии исключения

• Aphasia with severe anarthria (mutism), comprehension disorders or alexia, incompatible with the purpose of the study
• Contraindications for MRI
• History of head trauma, brain tumor, neurodegenerative disease, or any other neurological or psychiatric condition
• Non-affiliation to social welfare

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06712225 · RECHMPL22_0566

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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