- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Elodie GUILLOUET
- Telefonnummer: +33 0561779072
- E-post: guillouet.E@chu-toulouse.fr
Studiesteder
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Toulouse, Frankrike, 31300
- Service de Médecine Physique et de Réadaptation Hôpital Raymonde Fournet Purpan
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Ta kontakt med:
- Emeline Muller
- Telefonnummer: +33 0561778707
- E-post: muller.E@chu-toulouse.Fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Patients whose neuropsychological and speech-language pathology tests will be randomized
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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measure the proportion of patients with mild post-stroke aphasia exhibiting deficits in linguistic executive control within three months of a first stroke
Tidsramme: 7 days after the inclusion
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CATEX score result (deficit score if below the mean value minus 1.65 times the standard deviation)
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7 days after the inclusion
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Study of the correlation between executive control of language (CATEX score) and the score of the test evaluating access to the lexical stock
Tidsramme: 7 days after the inclusion
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7 days after the inclusion
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Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating access to the semantic system
Tidsramme: 7 days after the inclusion
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7 days after the inclusion
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Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating non-verbal executive control
Tidsramme: 7 days after the inclusion
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7 days after the inclusion
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Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating gnosies
Tidsramme: 7 days after the inclusion
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7 days after the inclusion
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Identification of patients' cognitive-linguistic impairment profiles based on cognitive test scores
Tidsramme: 7 days after the inclusion
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7 days after the inclusion
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Identification of patients' cognitive-linguistic impairment profiles based on stroke location using factor analysis
Tidsramme: 7 days after the inclusion
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7 days after the inclusion
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Nevroatferdsmanifestasjoner
- Kommunikasjonsforstyrrelser
- Språkforstyrrelser
- Taleforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Slag
- Afasi
Andre studie-ID-numre
- RC31/25/0614
- ID-RCB (Annen identifikator: 2025-A00414-45)
Plan for individuelle deltakerdata (IPD)
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