Clinical trial NCT06712225: Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: Pilot Study of Multidimensional Effects
Official title: Combining Anomia Therapy and Executive Function Training in Chronic Post-stroke Aphasia: a Pilot Study of Multidimensional Effects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Speech Therapy
Keywords: Post-stroke aphasia
Speech-therapy
Anomia therapy
Executive function
Discourse
Functional Magnetic Resonance Imaging
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in repeated measures of naming scores
timeFrame: 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:
measure: Comparison of pre and post intervention control naming scores for each group (arm A / arm B) and between groups.
timeFrame: 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
measure: Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Productivity (number of words produced / minute)
timeFrame: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention
measure: Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Informativity (% of correct information units)
timeFrame: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention
measure: Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Lexical diversity (type-token ratio)
timeFrame: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention
measure: Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Syntactic structure (Predicate Argument Structure)
timeFrame: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention
measure: Comparison of pre and post intervention discourse scores for each group (arm A / arm B) and between groups: Efficience (Main Concept Analysis)
timeFrame: First day of the baseline phase, 3,5 to 5 weeks after: first day of the experimental phase, and 4 weeks after the intervention
measure: MRI: Quantitative analyses
timeFrame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
measure: MRI: Qualitative analyses
timeFrame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
Other outcomes:
measure: Aphasia profile and severity score
timeFrame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
measure: Semantic association
timeFrame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
measure: Executive function: Modified Card Sorting Test
timeFrame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
measure: Executive function: Verbal fluency
timeFrame: Before the baseline and just after the intervention: 9,5 to 11 weeks after
measure: Questionnaire of Quality of Life
timeFrame: Before the baseline and 4 weeks after the intervention
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: Sylvie MORITZ-GASSER, Pr
role: PRINCIPAL_INVESTIGATOR
References: