Cohort Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Early and Remitting Relapsing Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Inventory Cognition (MUSIC)
研究概览
简要总结
This study is a cross sectional study of patients diagnosed with clinically isolated syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue severity and depressive symptoms. Cognitive impairment will be assessed with Multiple Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are validated for MS patients. In the second step we will use our large longitudinal database of serial MRI examinations from which a linear measurement of CCI will be retrospectively calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 55 years at presentation
- •Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005, clinically isolated syndrome suggestive of MS
- •Patients treated with interferon-beta 1b
- •Untreated patients
- •EDSS under 5.5
排除标准
- •Brain pathology other than MS
- •Known history of head trauma
- •Pure spinal manifestation of demyelization
- •Neuromyelitis optica
- •Primary and secondary progressive MS
- •Benzodiazepine intake within the last three months
- •Relapse within the last three months
- •Steroid intake within the last three months
- •History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
- •No informed consent
- •Insufficient knowledge of German
结局指标
主要结局
Multiple Sclerosis Inventory Cognition (MUSIC)
MUSIC is a cognitive screening instrument. It assesses the cognitive core deficit in MS (mental flexibility, attention, information processing speed, memory and inhibitory control) and includes 3 items derived from a factorial analysis to examine cognitive, motor and psychosocial fatigue, respectively.
Annual Corpus Callosum Index decrease
Corpus callosum index (CCI) is an easy to use MRI marker for estimating brain atrophy in patients with MS. Demonstrated correlation of CCI and atrophy has been measured with brain parenchymal fraction.
次要结局
- Corpus callosum Index at baseline
- Time to clinically definite MS
- The Symbol Digit Modalities Test (SDMT)
- Ratio treatment duration to disease duration