- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elodie GUILLOUET
- 전화번호: +33 0561779072
- 이메일: guillouet.E@chu-toulouse.fr
연구 장소
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Toulouse, 프랑스, 31300
- Service de Médecine Physique et de Réadaptation Hôpital Raymonde Fournet Purpan
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연락하다:
- Emeline Muller
- 전화번호: +33 0561778707
- 이메일: muller.E@chu-toulouse.Fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 7 days after the inclusion
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7 days after the inclusion
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC31/25/0614
- ID-RCB (기타 식별자: 2025-A00414-45)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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