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

Not Applicable

Not yet recruiting

• Conditions: Aphasia, Acquired; Speech Therapy

• Registration Number: NCT06712225
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Study Start: 2025-01
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in repeated measures of naming scores	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)	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of pre and post intervention control naming scores for each group (arm A / arm B) and between groups.	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	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.
Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Productivity (number of words produced / minute)	First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention	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.
Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Lexical diversity (type-token ratio)	First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention	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.
Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Syntactic structure (Predicate Argument Structure)	First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention	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.
Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Efficience (Main Concept Analysis)	First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention	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.
Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Informativity (% of correct information units)	First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention	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.
MRI: Quantitative analyses	Before the baseline and just after the intervention: 9,5 to 11 weeks after	Location of the cerebral vascular accident (3DT1) and analysis of lesion volumes (3D FLAIR)
MRI: Qualitative analyses	Before the baseline and just after the intervention: 9,5 to 11 weeks after	Functional connectivity: Task-based functional MRI (Naming, phonological and semantic processes); Rest-based functional MRI