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NCT Number: NCT06930131

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semantic rehabilitation

Behavioral

Semantic rehabilitation, consisting of validated lexico-phonological training exercises

Primary outcomes

  1. 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
    • quantitatively : number of "set success"
    • 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.

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lola DANET

CONTACT

[email protected]

05 61 77 76 86

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: METALEX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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