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

NCT06712225 | Not Yet Recruiting

• 1 other identifier: RECHMPL22_0566
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Conditions

Aphasia, Acquired; Speech Therapy

Keywords

Post-stroke aphasia; Speech-therapy; Anomia therapy; Executive function; Discourse; Functional Magnetic Resonance Imaging

Outcome Measures

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.

  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.

  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: 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

• 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

Other Outcomes (5)

• Aphasia profile and severity score

  Before the baseline and just after the intervention: 9,5 to 11 weeks after

• Semantic association

  Before the baseline and just after the intervention: 9,5 to 11 weeks after

• Executive function: Modified Card Sorting Test

  Before the baseline and just after the intervention: 9,5 to 11 weeks after

Study Arms (2)

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

Interventions

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.

Arm A: Anomia Therapy alone; Arm B: Anomia Therapy + Executive Function Training

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.

Arm B: Anomia Therapy + Executive Function Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Aphasia; Communication Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sylvie MORITZ-GASSER, Pr

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie MORITZ-GASSER, Pr

CONTACT

0620472276; s-moritzgasser@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11