ClinicalTrials.gg
RecruitingNCT06930131METALEXUpdated Nov 5, 2026

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

An interventional study of Semantic rehabilitation in Aphasia and Stroke, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Updated Nov 5, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Aphasia
  • Stroke

Keywords

  • Aphasia
  • Stroke
  • Chronic
  • Cognitive rehabilitation
  • SCED
03

In context

Aphasia

338 studies on the registry are indexed under Aphasia; 95 are open to participants now.

This study's planned enrollment of 18 is below the median of 30 across 298 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Other
    6 weeks phase A (Baseline)

    Behavioral: Semantic rehabilitation

  • Other
    7 weeks phase A (Baseline)

    Behavioral: Semantic rehabilitation

  • Other
    8 weeks phase A (Baseline)

    Behavioral: Semantic rehabilitation

Interventions

  • BehavioralSemantic rehabilitation

    Semantic rehabilitation, consisting of validated lexico-phonological training exercises

06

What researchers measure

Primary outcomes

  1. Performance at the "TD-264" untrained naming items task

    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.

    Time frame: Baseline, Up to 8 weeks, Up to 13 weeks

Secondary outcomes

  1. Reorganization of patients' functional connectivity maps compared to healthy volunteers

    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)

    Time frame: Up to 8 weeks ; Up to 13 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 2026→Dec 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Primary completion Aug 2026→Dec 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06930131
Responsible party
Sponsor
First posted
Apr 16, 2025
Start date
Feb 21, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Lola DANET
Contact
danet.l@chu-toulouse.fr
05 61 77 76 86

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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