Validation of the Performance of the French Version of the Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a Screening Test for Cerebellar Cognitive-affective Syndrome: a National Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale
研究概览
简要总结
The primary objective of the study is to assess the performance of the French version of the Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a screening test for cerebellar cognitive-affective syndrome.
The primary endpoint will be the sensitivity of version 1A of the French scale. The result will be considered positive if the patient fails at least one of the scale's subtests. The diagnosis of a cerebellar cognitive-affective syndrome will be made on the basis of a pathological score in the executive, language, visuospatial or psychoaffective domains of the neuropsychological evaluation (gold standard).
详细描述
Secondary objectives:
- To determine the other accuracy measures for version 1A of the French CCAS scale;
- To determine the performance indices (i.e., sensitivity, specificity) of French versions 1B, 1C and 1D of CCAS scale;
- To determine the performance indices of versions 1A, 1B, 1C, and 1D of CCAS scale when positivity is defined by ≥ 2 or ≥ 3 failed subtests, respectively;
- To evaluate the consistency of results from versions 1B, 1C and 1D compared with version 1A;
- To assess the inter-rater reliability of the different versions of the French scale;
- To assess the learning effect on version 1A of the French scale in the subgroup of patients included at Mulhouse hospital;
- To measure the time taken by patients to complete version 1A of the French scale.
Conduct of research:
The study will take place in the following french centers: GHRMSA - Hôpital Emile Muller (Mulhouse), AP-HP - Hôpital Pitié-Salpêtrière (Paris), CHRU Nancy - Hôpital Central (Nancy), Hôpitaux civils de Colmar (Colmar).
- V0 Screening: The protocol will be proposed to all eligible patients by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity of the 1A French version of the cerebellar cognitive-affective syndrome scale
时间窗: Up to 7 days
次要结局
- Total raw score on version 1A at V3(Up to 100 days)
- Time to complete version 1A of the French scale(Day 1)
- Specificity of the 1A French version of the cerebellar cognitive-affective syndrome scale(Up to 7 days)
- Concordance between the total raw score of version 1A and the total raw score of versions 1B, 1C, 1D, evaluated graphically using the Bland and Altman method(Day 1)
- Inter-rater agreement measured on the total raw score of the different versions of the French scale by calculating the intraclass correlation coefficient and using the Bland and Altman method(Day 1)
- Sensitivity and specificity of the 1B, 1C and 1D French versions of the cerebellar cognitive-affective syndrome scale(Up to 7 days)
- Sensitivity and specificity measured on the different versions of CCASS when a positive result is defined by ≥ 2 or ≥ 3 failed subtests respectively.(Up to 7 days)