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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:
Researchers will compare anomia therapy alone to anomia therapy + executive function training to see if the latter works better.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Anomia Therapy alone | Active Comparator |
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| Arm B: Anomia Therapy + Executive Function Training | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anomia therapy: semantic feature analysis and phonological components analysis; | Behavioral | 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 language + fMRI will then be conducted and participants will return to their usual rehabilitation. Four weeks later, a final assessment of naming and discourse will be conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in repeated measures of naming scores | Naming skills will be repeatedly assessed for each participant every 2 or 3 sessions during the 3,5 to 5 weeks of the baseline phase (usual rehabilitation): 5 to 7 measures, and during the 6 weeks of the experimental phase: 6 to 9 measures. A naming task specifically designed for the study ("Deno 100"), including 100 black and white line drawing pictures will be used to this end. Scores will range from 0 (no item correctly named) to 100 (all items correctly named). A visual analysis (mean and trend) and statistical analyses will then be applied in order to measure the effect of the experimental treatment on treated words and the effect size. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pre and post intervention control naming scores for each group (arm A / arm B) and between groups. | In order to measure the effects of the experimental treatment on non-treated words (transfer), a control naming task (French Battery of lexical disorders assessment, score range [0-54]) will be administered to each participant. Mean scores will be compared for each group at several times, and between groups at each time. |
| Measure | Description | Time Frame |
|---|---|---|
| Aphasia profile and severity score | The aphasia profile and severity score will be determined by means of the Quick Aphasia Battery. Scores range from 0 to 10: < 5 = severe aphasia; 5 to 7,5 = moderate aphasia; 7,5 to 8,9 = mild aphasia | Before the baseline and just after the intervention: 9,5 to 11 weeks after |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvie MORITZ-GASSER, Pr | Contact | 0620472276 | s-moritzgasser@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sylvie MORITZ-GASSER, Pr | University Hospital, Montpellier | Principal Investigator |
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| Executive function training: computerized equipment | Behavioral | 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. |
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| 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) | In order to measure the effects of the experimental treatment on discourse abilities (transfer), five samples of discourse will be collected from each participant (two picture descriptions, one wordless picture book-supported narrative, one personal narrative and one procedural information). Different scores will be calculated: productivity (number of words produced / min), informativity (% of correct information units), lexical diversity (type-token ratio), syntactic structure (Predicate Argument Structure), and efficience (Main Concept Analysis). These scores will be compared for each group at several times, and between groups at each time. | 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) | In order to measure the effects of the experimental treatment on discourse abilities (transfer), five samples of discourse will be collected from each participant (two picture descriptions, one wordless picture book-supported narrative, one personal narrative and one procedural information). Different scores will be calculated: productivity (number of words produced / min), informativity (% of correct information units), lexical diversity (type-token ratio), syntactic structure (Predicate Argument Structure), and efficience (Main Concept Analysis). These scores will be compared for each group at several times, and between groups at each time. | 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) | In order to measure the effects of the experimental treatment on discourse abilities (transfer), five samples of discourse will be collected from each participant (two picture descriptions, one wordless picture book-supported narrative, one personal narrative and one procedural information). Different scores will be calculated: productivity (number of words produced / min), informativity (% of correct information units), lexical diversity (type-token ratio), syntactic structure (Predicate Argument Structure), and efficience (Main Concept Analysis). These scores will be compared for each group at several times, and between groups at each time. | 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) | In order to measure the effects of the experimental treatment on discourse abilities (transfer), five samples of discourse will be collected from each participant (two picture descriptions, one wordless picture book-supported narrative, one personal narrative and one procedural information). Different scores will be calculated: productivity (number of words produced / min), informativity (% of correct information units), lexical diversity (type-token ratio), syntactic structure (Predicate Argument Structure), and efficience (Main Concept Analysis). These scores will be compared for each group at several times, and between groups at each time. | 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) | In order to measure the effects of the experimental treatment on discourse abilities (transfer), five samples of discourse will be collected from each participant (two picture descriptions, one wordless picture book-supported narrative, one personal narrative and one procedural information). Different scores will be calculated: productivity (number of words produced / min), informativity (% of correct information units), lexical diversity (type-token ratio), syntactic structure (Predicate Argument Structure), and efficience (Main Concept Analysis). These scores will be compared for each group at several times, and between groups at each time. | 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 | Location of the cerebral vascular accident (3DT1) and analysis of lesion volumes (3D FLAIR) | Before the baseline and just after the intervention: 9,5 to 11 weeks after |
| MRI: Qualitative analyses | Functional connectivity: Task-based functional MRI (Naming, phonological and semantic processes); Rest-based functional MRI | Before the baseline and just after the intervention: 9,5 to 11 weeks after |
| Semantic association |
Semantic processing will be assessed by means of the semantic association task of the French Battery of lexical disorders assessment, in which the participant is asked to match semantically related pictures (score range [0-54]) |
| Before the baseline and just after the intervention: 9,5 to 11 weeks after |
| Executive function: Modified Card Sorting Test | The Modified Card Sorting Test explores flexibility, inhibition, updating and attention skills through a card sorting task following 3 rules: colour, number and shape. | Before the baseline and just after the intervention: 9,5 to 11 weeks after |
| Executive function: Verbal fluency | Each participant will be asked to produce words beginning with the letter /p/ in 2 minutes and then names of animals during 2 minutes. The number of words produced in each category will be compared with French norms (Grefex) | Before the baseline and just after the intervention: 9,5 to 11 weeks after |
| Questionnaire of Quality of Life | In order to measure the functional effects of the experimental treatment, a quality of life scale (Stroke and Aphasia Quality of Life scale: score ranging from 1: low quality of life to 39: good quality of life) will be completed. | Before the baseline and 4 weeks after the intervention |
| ID | Term |
|---|---|
| D001037 | Aphasia |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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