An interventional study of Anomia therapy: semantic feature analysis and phonological components analysis; and Executive function training: computerized equipment in Aphasia, Acquired and Speech Therapy, sponsored by University Hospital, Montpellier. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment
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:
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 8 is below the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Anomia therapy: semantic feature analysis and phonological components analysis;
Behavioral: Anomia therapy: semantic feature analysis and phonological components analysis; · Behavioral: Executive function training: computerized equipment
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.
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.
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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
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
Time frame: 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 \[0-54\])
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Before the baseline and 4 weeks after the intervention
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →