Aphasia, AcquiredATAC2PILOTNCT06712225
Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: Pilot Study of Multidimensional Effects
A study testing Anomia therapy: semantic feature analysis and phonological components analysis; and Executive function training: computerized equipment in people with Aphasia, Acquired and Speech Therapy, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia, Acquired, Speech Therapy
- What is being tested?
- Anomia therapy: semantic feature analysis and phonological components analysis; and Executive function training: computerized equipment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combining Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: a Pilot Study of Multidimensional Effects
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:
Read more
- 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
- Conditions
- Aphasia, Acquired, Speech Therapy
- Being tested
- Anomia therapy: semantic feature analysis and phonological components analysis;, Executive function training: computerized equipment
- Keywords
- Post-stroke aphasia, Speech-therapy, Anomia therapy, Executive function, Discourse, Functional Magnetic Resonance Imaging
- Medical subject headings
- Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anomia therapy: semantic feature analysis and phonological components analysis;Behavioural
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 equipmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Anomia Therapy alone | Active comparator | Not described Receives: Behavioral: Anomia therapy: semantic feature analysis and phonological components analysis; |
| Arm B: Anomia Therapy + Executive Function Training | Experimental | Not described Receives: Behavioral: Anomia therapy: semantic feature analysis and phonological components analysis;; Behavioral: Executive function training: computerized equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: Before the baseline and just after the intervention: 9,5 to 11 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie MORITZ-GASSER, Pr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712225
- Sponsor's protocol ID
- RECHMPL22_0566
- Acronym
- ATAC2PILOT
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: a Pilot Study of Multidimensional Effects
- ClinicalTrials.gov ID
- NCT06712225
- Acronym / sponsor ID
- ATAC2PILOT / RECHMPL22_0566
- Conditions
- Aphasia, Acquired, Speech Therapy
- Keywords
- Post-stroke aphasia, Speech-therapy, Anomia therapy, Executive function, Discourse, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Anomia Therapy alone | Active comparator | Behavioral: Anomia therapy: semantic feature analysis and phonological components analysis; |
| Arm B: Anomia Therapy + Executive Function Training | Experimental | Behavioral: Anomia therapy: semantic feature analysis and phonological components analysis;, Behavioral: Executive function training: computerized equipment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anomia 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. | Behavioural | Arm A: Anomia Therapy alone, Arm B: Anomia Therapy + Executive Function Training |
| Executive function training: computerized equipmentExecutive 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. | Behavioural | Arm B: Anomia Therapy + Executive Function Training |
Primary outcome
Change in repeated measures of naming scores
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)
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.
8 secondary outcomes
Comparison of pre and post intervention control naming scores for each group (arm A / arm B) and between groups.
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)
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)
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)
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)
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)
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
Time frame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
MRI: Qualitative analyses
Time frame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvie MORITZ-GASSER, Pr principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Anomia therapy: semantic feature analysis and phonological components analysis; and Executive function training: computerized equipment in people with Aphasia, Acquired and Speech Therapy, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie MORITZ-GASSER, Pr (0620472276, s-moritzgasser@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in repeated measures of naming scores (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.