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

NCT ID: NCT06712225

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A: Anomia Therapy alone

Group Type: ACTIVE_COMPARATOR

Anomia therapy: semantic feature analysis and phonological components analysis;

Intervention Type: 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 B: Anomia Therapy + Executive Function Training

Group Type: EXPERIMENTAL

Anomia therapy: semantic feature analysis and phonological components analysis;

Intervention Type: 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.

Executive function training: computerized equipment

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie MORITZ-GASSER, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Central Contacts

Sylvie MORITZ-GASSER, Pr

Role: CONTACT

s-moritzgasser@chu-montpellier.fr

0620472276

Other Identifiers

RECHMPL22_0566

Identifier Type: -

Identifier Source: org_study_id