StrokeP-CLACNCT07766356
Study of Cognitive-Linguistic Profiles: The Role of Executive Control in Aphasia
A study testing Neuropsychological tests and Speech-language assessments in people with Stroke, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In France, stroke affects 150,000 people annually and is the leading cause of acquired disability in adults; 10-12% of patients exhibit mild post-stroke aphasia, a condition defined by language difficulties. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neuropsychological tests and Speech-language assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 8 Sep 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has experienced a first ischemic stroke resulting in clinical symptoms within the last 3 months and is receiving care in the Physical Medicine and Rehabilitation department.
- Score ≤ 31 on the conversational speech observation scale of the MEC test (Montreal Protocol for the Evaluation of Communication).
- Patients with a BDAE score ≥ 3 (Boston Diagnostic Aphasia Examination - French version, Mazaux J.-M. [1990]); this score is the gold standard in aphasiology.
- Native French-speaking patient capable of understanding oral or written instructions.
Who cannot join
- Patients exhibiting behavior or a clinical condition incompatible with test administration, as assessed by the clinician.
- Known major visual, auditory, or motor impairments incompatible with test performance.
- Known neurodegenerative and/or neurodevelopmental disorders.
- Known social cognition disorders (e.g., ASD).
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
Service de Médecine Physique et de Réadaptation Hôpital Raymonde Fournet Purpan
Toulouse, 31300
Emeline MULLER, 0561778707 ext. +33, muller.E@chu-toulouse.Fr
About this study
Official title: Study of Cognitive-linguistic Profiles in Brain-injured Adults: the Role of Executive Control in Mild Aphasia.
In France, stroke affects 150,000 people annually and is the leading cause of acquired disability in adults; 10-12% of patients exhibit mild post-stroke aphasia, a condition defined by language difficulties.
Few studies describe mild post-stroke aphasia, and none characterize the impairment of linguistic executive control in this population; consequently, its prevalence remains unknown. To date, the role of linguistic executive control in mild aphasia remains an open question.
The aim of this project is to investigate linguistic executive control impairment in stroke survivors with mild aphasia, provide an initial estimate of its prevalence, and demonstrate its interactions with other linguistic and communicative aspects, as well as with executive and attentional functions.
- Conditions
- Stroke
- Being tested
- Neuropsychological tests, Speech-language assessments
- Keywords
- stroke, aphasia, AVC
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic test
Patients undergo neuropsychological tests, the order of which will be randomized.
Speech-language assessmentsDiagnostic test
Patients will undergo speech-language assessments, with the order of the tests randomized.
| Study group | Role | What they receive |
|---|---|---|
| Patients whose neuropsychological and speech-language pathology tests will be randomized | Experimental | Not described Receives: Diagnostic Test: Neuropsychological tests; Diagnostic Test: Speech-language assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the proportion of patients with mild post-stroke aphasia exhibiting deficits in linguistic executive control within three months of a first stroke
CATEX score result (deficit score if below the mean value minus 1.65 times the standard deviation)
Measured: 7 days after the inclusion
Secondary outcomes (6)
Study of the correlation between executive control of language (CATEX score) and the score of the test evaluating access to the lexical stock
Measured: 7 days after the inclusion
Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating access to the semantic system
Measured: 7 days after the inclusion
Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating non-verbal executive control
Measured: 7 days after the inclusion
Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating gnosies
Measured: 7 days after the inclusion
Identification of patients' cognitive-linguistic impairment profiles based on cognitive test scores
Measured: 7 days after the inclusion
Identification of patients' cognitive-linguistic impairment profiles based on stroke location using factor analysis
Measured: 7 days after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion8 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07766356
- Sponsor's protocol ID
- RC31/25/0614
- Other IDs
- ID-RCB
- Acronym
- P-CLAC
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cognitive-linguistic Profiles in Brain-injured Adults: the Role of Executive Control in Mild Aphasia.
- ClinicalTrials.gov ID
- NCT07766356
- Acronym / sponsor ID
- P-CLAC / RC31/25/0614
- Conditions
- Stroke
- Keywords
- stroke, aphasia, AVC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 8 Sep 2028 (estimated)
- First posted
- 14 Aug 2026 (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.
In France, stroke affects 150,000 people annually and is the leading cause of acquired disability in adults; 10-12% of patients exhibit mild post-stroke aphasia, a condition defined by language difficulties.
Few studies describe mild post-stroke aphasia, and none characterize the impairment of linguistic executive control in this population; consequently, its prevalence remains unknown. To date, the role of linguistic executive control in mild aphasia remains an open question.
The aim of this project is to investigate linguistic executive control impairment in stroke survivors with mild aphasia, provide an initial estimate of its prevalence, and demonstrate its interactions with other linguistic and communicative aspects, as well as with executive and attentional functions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients whose neuropsychological and speech-language pathology tests will be randomized | Experimental | Diagnostic Test: Neuropsychological tests, Diagnostic Test: Speech-language assessments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who has experienced a first ischemic stroke resulting in clinical symptoms within the last 3 months and is receiving care in the Physical Medicine and Rehabilitation department.
- Score ≤ 31 on the conversational speech observation scale of the MEC test (Montreal Protocol for the Evaluation of Communication).
- Patients with a BDAE score ≥ 3 (Boston Diagnostic Aphasia Examination - French version, Mazaux J.-M. [1990]); this score is the gold standard in aphasiology.
- Native French-speaking patient capable of understanding oral or written instructions.
Key exclusion criteria (4 listed)
- Patients exhibiting behavior or a clinical condition incompatible with test administration, as assessed by the clinician.
- Known major visual, auditory, or motor impairments incompatible with test performance.
- Known neurodegenerative and/or neurodevelopmental disorders.
- Known social cognition disorders (e.g., ASD).
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 |
|---|---|---|
| Neuropsychological testsPatients undergo neuropsychological tests, the order of which will be randomized. | Diagnostic test | Patients whose neuropsychological and speech-language pathology tests will be randomized |
| Speech-language assessmentsPatients will undergo speech-language assessments, with the order of the tests randomized. | Diagnostic test | Patients whose neuropsychological and speech-language pathology tests will be randomized |
Primary outcome
measure the proportion of patients with mild post-stroke aphasia exhibiting deficits in linguistic executive control within three months of a first stroke
Time frame: 7 days after the inclusion
CATEX score result (deficit score if below the mean value minus 1.65 times the standard deviation)
6 secondary outcomes
Study of the correlation between executive control of language (CATEX score) and the score of the test evaluating access to the lexical stock
Time frame: 7 days after the inclusion
Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating access to the semantic system
Time frame: 7 days after the inclusion
Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating non-verbal executive control
Time frame: 7 days after the inclusion
Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating gnosies
Time frame: 7 days after the inclusion
Identification of patients' cognitive-linguistic impairment profiles based on cognitive test scores
Time frame: 7 days after the inclusion
Identification of patients' cognitive-linguistic impairment profiles based on stroke location using factor analysis
Time frame: 7 days after the inclusion
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 14 Aug 2026.
- Individual participant dataSharing planned: No
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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 Neuropsychological tests and Speech-language assessments in people with 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Aug 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 Elodie GUILLOUET (0561779072 ext. +33, guillouet.E@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the proportion of patients with mild post-stroke aphasia exhibiting deficits in linguistic executive control within three months of a first stroke (time frame: 7 days after the inclusion). 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 14 Aug 2026.