AphasiaMETALEXNCT06930131
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
A study testing Semantic rehabilitation in people with Aphasia and Stroke, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Semantic rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Toulouse
Toulouse
Lola Danet, phD, danet.l@chu-toulouse.fr
About this study
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.
- Being tested
- Semantic rehabilitation
- Keywords
- Aphasia, Stroke, Chronic, Cognitive rehabilitation, SCED
- Medical subject headings
- Aphasia, Stroke, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semantic rehabilitationBehavioural
Semantic rehabilitation, consisting of validated lexico-phonological training exercises
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks phase A (Baseline) | Other | Not described Receives: Behavioral: Semantic rehabilitation |
| 7 weeks phase A (Baseline) | Other | Not described Receives: Behavioral: Semantic rehabilitation |
| 8 weeks phase A (Baseline) | Other | Not described Receives: Behavioral: Semantic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
Measured: 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)
Measured: Up to 8 weeks ; Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start21 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930131
- Sponsor's protocol ID
- RC31/22/0503
- Other IDs
- 2024-A01842-45
- Acronym
- METALEX
- Status last verified
- Nov 2026
- First submitted
- 19 Feb 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
- ClinicalTrials.gov ID
- NCT06930131
- Acronym / sponsor ID
- METALEX / RC31/22/0503
- Keywords
- Aphasia, Stroke, Chronic, Cognitive rehabilitation, SCED
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 weeks phase A (Baseline) | Other | Behavioral: Semantic rehabilitation |
| 7 weeks phase A (Baseline) | Other | Behavioral: Semantic rehabilitation |
| 8 weeks phase A (Baseline) | Other | Behavioral: Semantic rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semantic rehabilitationSemantic rehabilitation, consisting of validated lexico-phonological training exercises | Behavioural | 6 weeks phase A (Baseline), 7 weeks phase A (Baseline), 8 weeks phase A (Baseline) |
Primary outcome
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.
1 secondary outcome
Reorganization of patients' functional connectivity maps compared to healthy volunteers
Time frame: Up to 8 weeks ; Up to 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semantic rehabilitation in people with Aphasia and Stroke, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lola DANET (05 61 77 76 86, danet.l@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance at the "TD-264" untrained naming items task (time frame: Baseline, Up to 8 weeks, Up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.