- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Elodie GUILLOUET
- Telefonnummer: +33 0561779072
- E-post: guillouet.E@chu-toulouse.fr
Studieorter
-
-
-
Toulouse, Frankrike, 31300
- Service de Médecine Physique et de Réadaptation Hôpital Raymonde Fournet Purpan
-
Kontakt:
- Emeline Muller
- Telefonnummer: +33 0561778707
- E-post: muller.E@chu-toulouse.Fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
measure the proportion of patients with mild post-stroke aphasia exhibiting deficits in linguistic executive control within three months of a first stroke
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Study of the correlation between executive control of language (CATEX score) and the score of the test evaluating access to the lexical stock
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 7 days after the inclusion
|
7 days after the inclusion
|
|
Identification of patients' cognitive-linguistic impairment profiles based on cognitive test scores
Tidsram: 7 days after the inclusion
|
7 days after the inclusion
|
|
Identification of patients' cognitive-linguistic impairment profiles based on stroke location using factor analysis
Tidsram: 7 days after the inclusion
|
7 days after the inclusion
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Neurobehavioral manifestationer
- Kommunikationsstörningar
- Språkstörningar
- Talstörningar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Stroke
- Afasi
Andra studie-ID-nummer
- RC31/25/0614
- ID-RCB (Annan identifierare: 2025-A00414-45)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .