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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06712225
Acronym
ATAC2PILOT
Enrollment
8
Registered
2024-12-02
Start date
2025-01-31
Completion date
2025-10-31
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Acquired, Speech Therapy

Keywords

Post-stroke aphasia, Speech-therapy, Anomia therapy, Executive function, Discourse, Functional Magnetic Resonance Imaging

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

Interventions

BEHAVIORALAnomia 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 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.

BEHAVIORALExecutive 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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in repeated measures of naming scoresEvery 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

MeasureTime frameDescription
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 interventionIn 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 interventionIn 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 interventionIn 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 interventionIn 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 interventionIn 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 analysesBefore the baseline and just after the intervention: 9,5 to 11 weeks afterLocation of the cerebral vascular accident (3DT1) and analysis of lesion volumes (3D FLAIR)
MRI: Qualitative analysesBefore the baseline and just after the intervention: 9,5 to 11 weeks afterFunctional connectivity: Task-based functional MRI (Naming, phonological and semantic processes); Rest-based functional MRI
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 afterIn 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.

Other

MeasureTime frameDescription
Executive function: Modified Card Sorting TestBefore the baseline and just after the intervention: 9,5 to 11 weeks afterThe Modified Card Sorting Test explores flexibility, inhibition, updating and attention skills through a card sorting task following 3 rules: colour, number and shape.
Executive function: Verbal fluencyBefore the baseline and just after the intervention: 9,5 to 11 weeks afterEach 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)
Questionnaire of Quality of LifeBefore the baseline and 4 weeks after the interventionIn 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.
Aphasia profile and severity scoreBefore the baseline and just after the intervention: 9,5 to 11 weeks afterThe 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
Semantic associationBefore the baseline and just after the intervention: 9,5 to 11 weeks afterSemantic 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 \[0-54\])

Contacts

Primary ContactSylvie MORITZ-GASSER, Pr
s-moritzgasser@chu-montpellier.fr0620472276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026