Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia (METALEX)

April 15, 2025 updated by: University Hospital, Toulouse
The postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks. In addition, it could potentiate the generalisation of effects to verbal and non-verbal communication skills, having a direct impact on patients' quality of life. This research is a prospective, randomized controlled, open-label, single-centre study. It is part of the management of patients with aphasia who have suffered a cerebral infarction and aims to evaluate the effect of combined language semantics/metacognition rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vascular aphasia occurs after 20 to 25% of strokes and leads to anomia or word-finding difficulties in many patients. Speech therapy, which is the standard treatment, notably employs Semantic Feature Analysis (SFA). SFA aims to teach patients a strategy that helps activate semantic links strongly associated with the target word, thereby facilitating word retrieval.

Moreover, a growing number of studies suggest combining metacognitive strategy training with language rehabilitation in brain-injured patients, particularly in reading comprehension, communication skills, and anomia, could improve cognitive and language recovery outcomes. In rehabilitation, metacognitive strategy training can be used to enhance and/or compensate for cognitive function deficits. Patients are repeatedly exposed to discrepancies between the patients performance evaluations and expectations. Findings indicate improvements in trained tasks and transfer effects to similar tasks.

While studies have examined the effects of linguistic training on one hand and the impact of metacognitive abilities on the other, to the investigators knowledge, no study has assessed the effect of a combined linguistic and metacognitive training approach in post-stroke aphasic patients on behavioral and imaging variables. This study postulates that rehabilitation combining linguistic and metacognitive training will lead to a significant improvement in language performance, correlated with changes in functional brain connectivity networks. Furthermore, it may enhance the generalization of effects to both verbal and non-verbal communication skills, directly impacting patients' quality of life.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • First cerebral infarction
  • Chronic phase (> 3 months)
  • Patient affiliated to a health insurance scheme
  • Usual french language
  • Severity score measures using the Boston Diagnostic Aphasia Examination battery scale corresponding to the mild or moderate level (score greater than or equal to 2)

Exclusion Criteria:

  • Contraindication to undergoing brain MRI
  • Cognitive impairment pre-existing stroke (CQI code > 3.4) (Law et al., 1995)
  • Chronic alcohol or drug abuse
  • Unstabilised psychiatric illness
  • Uncorrected sensory deficits
  • Diagnosed as having a progressive general pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 6 weeks phase A (Baseline)
Behavioral: Semantic rehabilitation
Semantic rehabilitation, consisting of validated lexico-phonological training exercises
Other: 7 weeks phase A (Baseline)
Behavioral: Semantic rehabilitation
Semantic rehabilitation, consisting of validated lexico-phonological training exercises
Other: 8 weeks phase A (Baseline)
Behavioral: Semantic rehabilitation
Semantic rehabilitation, consisting of validated lexico-phonological training exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance at the "TD-264" untrained naming items task
Time Frame: Baseline, Up to 8 weeks, Up to 13 weeks

The "TD-264 untrained naming items task" is a naming task of 264 images. Words corresponding to the images correctly named are "set success" and words wrongly named are "set treatment".

The score at the task is composite :

  • reaction time allowing the speed of evocation to be measured will be measured with the Audacity software (https://audacity.fr/).

  • accuracy will be rated

    1. quantitatively : number of "set success"
    2. qualitatively : description of naming behaviors

Scores are all from 0 to 264. 0 being the worst performance possible and 264 being the best performance possible.
Baseline, Up to 8 weeks, Up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reorganization of patients' functional connectivity maps compared to healthy volunteers
Time Frame: Up to 8 weeks ; Up to 13 weeks
Reorganization of the functional connectivity of patients measured by the difference between the activation maps at the end of phase A and at the end of phase B, thanks to the acquisition of resting functional MRI sequences on the MRI dedicated to research (acquisition of resting-state MRI sequences)
Up to 8 weeks ; Up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/22/0503
  • 2024-A01842-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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