EYE-SEP : Study of Social Cognition in Patients With Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)
研究概览
简要总结
This study aims to:
- analyze prospectively the prevalence of subclinical oculomotor disorders (OMDs) in different phenotypes of Multiple Sclerosis (MS) and to study correlations with brain MRI T2 data.
- highlight link between modification of visual exploration strategies to decode emotions, and social behavioral disorders, in patients with demyelinating disease, from early to clinically definite stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Male or Female.
- •18 years old and above.
- •Sufficient written and oral expression in French.
- •Covered by a health insurance system
- •Written informed consent signed by the patient.
- •For the MS group:
- •* Patient diagnosed according to diagnostic criteria established by Polman et al. (2010): Radiologically Isolated Syndrome compatible with MS (RIS), Clinically Isolated Syndrome compatible with MS (CIS), Relapsing-Remitting MS, Secondary Progressive MS, or Primary Progressive MS.
- •* Hospitalized or coming to perform a consultation.
- •For the control group: No cognitive impairment (non pathological Mini-Mental State Examination (MMSE), according to age, gender and socio-cultural level).
排除标准
- •General anaesthesia within 3 months.
- •Ophthalmological problems preventing a video-oculography examination.
- •Oculomotor disorders:
- •For the control group: "fixation disorders" or "ocular tracking disorders".
- •For the MS group: atypical disorders.
- •Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
- •Other neurological or ophthalmological disorders than MS
- •History of stroke.
- •Psychotropic drugs consummation.
结局指标
主要结局
Eye gaze strategies during Emotion recognition: Affective Theory of Mind (ToM)
时间窗: Day 0
Comparison of gaze patterns between control group and pathological groups, during Affective ToM task. Evaluation criteria: number and duration of fixations. Eye movements were recorded with an eye-tracking device. Affective ToM was assessed using the " Reading the Mind in the Eyes " test (Baron-Cohen 2001).
Eye gaze strategies during Emotion recognition assessment: Facial emotion recognition (FER)
时间窗: Day 0
Comparison of gaze patterns between control group and pathological groups, during Facial emotion recognition tasks. Evaluation criteria: number and duration of fixations on areas of interest. Eye movements were recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).
Prevalence of Oculomotor disorders (OMD)
时间窗: Day 0
To analyze prevalence of OMD in different MS phenotypes Eye movements were recorded and analyzed with an eye-tracking device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, smooth pursuit and anti-saccades). For each subject values were judged abnormal if they differed by \>1.65 Standard Deviation (SD) compared to their reference sample.
次要结局
- T2 MRI lesion location: T2 lesions load(Day 0)
- Correlations between Emotion recognition and disability level.(Day 0)
- T2 MRI lesion location: Posterior fossa lesions(Day 0)
- Disease Disability(Day 0)
- T2 MRI lesion location: Spinal cord lesions(Day 0)
- Oculomotor paradigms raw performance - Horizontal saccades(Day 0)
- Oculomotor paradigms raw performance - Vertical saccades(Day 0)
- Disease Duration(Day 0)
- Correlations between visual exploration strategies and behavioral disorders.(Day 0)
- Correlations between visual exploration strategies and social cognition impairment: Facial emotion recognition.(Day 0)
- Correlations between visual exploration strategies and social cognition impairment: Affective ToM.(Day 0)
- Correlations between Facial emotion recognition and behavioral disorders.(Day 0)
- Correlations between Affective empathy and disability level.(Day 0)
- Eye gaze strategies during exploration of a specific artwork(Day 0)
- Correlations between Emotion recognition and behavioral disorders.(Day 0)
- Correlations between Facial emotion recognition and disability level.(Day 0)
- Correlations between Cognitive Theory of mind and disability level.(Day 0)