- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02874482
Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia (SAILLANCE1)
Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia
Background:
Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).
The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.
Main aim:
The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.
Secondary objectives:
To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.
To separate an explicit response (motors responses) with an implicit response (eye tracking measures).
Methodology:
30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.
연구 개요
상태
정황
상세 설명
This study will include one visit:
- Written consent will be obtained from all participants
- Inclusion and exclusion criteria will be checked
- An ophthalmologic test, a pregnancy test, a alcohol test and a salivary test will be realized
- Various symptoms will be assessed with the PANSS (Positive And Negative Syndrome Scale for schizophrenia) and the UPDRS (Unified Parkinson Disease Rating Scale for patients, the MOCA (Montreal Cognitive Assessment), The HAD (Hospital Anxiety and Depression Scale) and the MINI (Mini International Neuropsychiatric Interview) for all participants.
- The task will be divided in two parts:
A visuo-spatial task allowing to record saccadic eye movements (approximately 10 min).
The change blindness session lasted approximately 20 min.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Lille, 프랑스, 59037
- University Hospital, Lille
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Normal or corrected vision
- Affiliate to a social security system
- For group of patients with schizophrenia : diagnosis of schizophrenia based on the standard DSM-IV criteria and patients will be clinically stable at the testing time
Exclusion Criteria:
- History of neurological illness
- Pregnant and nursing women
- Drugs use in the last 24 hours
- Acute ocular disorder
- Under tutorship, curatorship or deprived of liberty
- For controls group : be free DSM-IV axis-I diagnoses according the MINI test.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Patients with schizophrenia
30 patients with schizophrenia (diagnosis based on the standard DSM criteria)
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통제 수단
정신과 또는 신경학적 진단이 없는 30가지 건강한 대조군
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
response time
기간: 42 months
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The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.
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42 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
sensitivity index
기간: 42 months
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Performances will be measure by a sensitivity index (D prime) which considers the number of correct detections compared with the missed detections and false alarms; thus it evaluates the capacity to discriminate the signal against a background noise.
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42 months
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implicit response
기간: 42 months
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The implicit response will be measure by the localization and duration of fixations
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42 months
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emotional response
기간: 42 months
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The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli
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42 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Guillaume VAIVA, University Hospital, Lille
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .