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Not yet recruiting NCT06712225

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

No phase Interventional Aphasia, Acquired Speech Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anomia therapy: semantic feature analysis and phonological components analysis;, Executive function training: computerized equipment.
Who it may be relevant to
Registry conditions: Aphasia, Acquired, Speech Therapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Behavioral 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 l
  • Behavioral Executive function training: computerized equipment
    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.

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06712225 · RECHMPL22_0566

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗