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Clinical Trials/NCT06712225
NCT06712225
Not yet recruiting
Not Applicable

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

University Hospital, Montpellier0 sites8 target enrollmentJanuary 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aphasia, Acquired
Sponsor
University Hospital, Montpellier
Enrollment
8
Primary Endpoint
Change in repeated measures of naming scores
Status
Not yet recruiting
Last Updated
last year

Overview

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
Registry
clinicaltrials.gov
Start Date
January 2025
End Date
October 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 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)(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)(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)(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)(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)(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(Before the baseline and just after the intervention: 9,5 to 11 weeks after)
  • MRI: Qualitative analyses(Before the baseline and just after the intervention: 9,5 to 11 weeks after)

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