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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Montpellier

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: Arm A: Anomia Therapy aloneActive comparator 1 intervention
Group B: Arm B: Anomia Therapy + Executive Function TrainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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
4

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

Locations

This trial has no locations.

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