Emotions Recognition in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Emotion's intensity
研究概览
简要总结
Through this study, a group composed of multiple sclerosis patients will be compared to a healthy volunteers group to determine if the positive emotions recognitions is preserved in the first group.
详细描述
Different studies have highlighted the specific deficiency concerning emotions recognition in multiple sclerosis. Patients with multiple sclerosis are reported to have more difficulty recognising negative emotions, especially anger and fear.
In this context, RECODE study has a twofold objective:
- To determine whether the positive emotions recognition remains preserved by combining behavioural and neurophysiological measures (electrodermal activity).
- To study this disorder's etiology through a comparison between a multiple sclerosis patient group and a control group (matched in sex, age, and education's level).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 55 years old.
- •Understand and able to express themselves in French.
- •EXPERIMENTAL GROUP :
- •Relapsing-remitting form (RRMS)
- •With an EDSS < 4 (Expanded Disability Status Scale)
- •No significant motor, cerebellar or somatosensory disorders of the upper limbs or visual disorders (EDSS specific parameter <2)
- •No flare-up in the last 6 weeks
- •No corticosteroids taken in the last 4 weeks
- •CONTROL GROUP :
- •Lack of global cognitive deterioration (according to Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) standards).
- •Gender, age and education level matching to the multiple sclerosis patients
- •Understanding and signing the informed consent and information letter regarding participation in the study.
- •Benefiting from health insurance coverage.
排除标准
- •Persons with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general affections, perceptive or dysarthric disorders preventing verbal communication or reading,
- •People with sensory disorders (visual and auditory) that interfere with the performance of neuropsychological tests;
- •Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
- •Refusal to participate after clear and fair information about the study.
- •Major persons under guardianship, under judicial protection, persons deprived of liberty.
- •Pregnant or breastfeeding women
结局指标
主要结局
Emotion's intensity
时间窗: Day 0
Through the emotion recognition test, the attendees will have to evaluate the emotion's intensity conveyed by the stimuli on a scale ranging from 1 (the emotion conveyed is not very intense) to 10 (the emotion conveyed is very intense).
Emotion's valence
时间窗: Day 0
Through the emotion recognition test, the attendees will have to evaluate the emotion's valence conveyed by the stimuli on a scale ranging from 1 (the emotion conveyed is negative) to 10 (the emotion conveyed is positive).
Emotion recognition
时间窗: Day 0
Comparison of the answers obtained to the recognition question "In your opinion what is the emotion conveyed by this extract/face" in both groupsThrough the emotion recognition test, the attendees will have to evaluate the emotion perceived among 6 basic emotions (anger, disgust, joy, fear, surprise, sadness) and 14 complex emotions (benevolence, disappointment, boredom, enthusiasm, mischief, pride, frustration, shame, hostility, worry, interest, jealousy, sorrow, sneakiness).
Certainty's degree of answers
时间窗: Day 0
Certainty's degree of the attendees answers to the recognition question on a scale from 1 ("I am not at all certain of my answer") to 10 ("I am quite certain of my answer")
次要结局
- California Verbal Learning Test (CVLT)(Day 0)
- Brief Visuo-spatial Memory Test (BVMT)(Day 0)
- Trail Making test(Day 0)
- State Trait Anxiety Inventory Y-B (STAI Y-B)(Day 0)
- Beck Depression Inventory (BDI)(At the unique experimental session)
- Dot Probe Task(Day 0)
- Change in the electrodermal response during emotion recognition test(Day 0)
- Stroop test(Day 0)
- Symbol Digit Modalities Test (SDMT)(Day 0)
- Verbal fluency test(Dat 0)
- State Trait Anxiety Inventory Y-A (STAI Y-A)(Day 0)
- Toronto Alexithymia Scale-20 (TAS-20)(Day 0)