- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07766356
Study of Cognitive-Linguistic Profiles: The Role of Executive Control in Aphasia (P-CLAC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elodie GUILLOUET
- Phone Number: +33 0561779072
- Email: guillouet.E@chu-toulouse.fr
Study Locations
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-
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Toulouse, France, 31300
- Service de Médecine Physique et de Réadaptation Hôpital Raymonde Fournet Purpan
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Contact:
- Emeline Muller
- Phone Number: +33 0561778707
- Email: muller.E@chu-toulouse.Fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients whose neuropsychological and speech-language pathology tests will be randomized
|
Patients undergo neuropsychological tests, the order of which will be randomized.
Patients will undergo speech-language assessments, with the order of the tests randomized.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
7 days after the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
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
|
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
|
7 days after the inclusion
|
|
Identification of patients' cognitive-linguistic impairment profiles based on cognitive test scores
Time Frame: 7 days after the inclusion
|
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
|
7 days after the inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Aphasia
Other Study ID Numbers
- RC31/25/0614
- ID-RCB (Other Identifier: 2025-A02583-46)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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