Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Emotional memory performance
研究概览
简要总结
The aim of this prospective non-interventional neuropsychological one visit study involving functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects.
In different experiments, the modulation of cognitive and motor responses by visual emotional information and the ability to discriminate visual emotional stimuli will be tested using experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI - activations of brain regions known to be involved with emotional processing will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years and ≤ 85 years
- •Right handed
- •For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years
排除标准
- •Cognitive deficits as determined by a MMSE Score < 25/30
- •Depression as determined by a HADS-D Score > 7
- •Anxiety as determined by a HADS-A Score > 7
- •Physical disabilities interfering with the study procedures or impacting outcome measures
- •Clinically significant diseases within 7 days prior to the study evaluations
- •Contraindications against cranial MRI without contrast
结局指标
主要结局
Emotional memory performance
时间窗: 1 day
%-correct recognized emotional and neutral stimuli
Emotional modulation of motor response time
时间窗: 1 day
Δ (\[Response time following neutral stimuli\] - \[Response time following emotional stimuli\])
Emotional experience
时间窗: 1 day
Subjective valence and arousal ratings of emotional and neutral stimuli
次要结局
- Satisfaction With Life Scale (SWLS)(1 day)
- Short Form Health Survey (SF-36)(1 day)
- Expanded Disability Status Scale (EDSS)(1 day)
- Multiple Sclerosis Functional Composite (MSFC)(1 day)
- Symbol Digit Modalities Test (SDMT)(1 day)
- Serial Reaction Time (SRT) Task(1 day)
- BOLD-fMRI brain responses during emotional processing(1 day)
- Paced Auditory Serial Addition Test (PASAT)(1 day)
- Beck depression inventory BDI-2(1 day)
- Positive and Negative Affect Schedule (PANAS)(1 day)
研究者
PD Dr. Thomas Hälbig
MD
Charite University, Berlin, Germany