Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis
2010年11月30日 更新者：Cantonal Hospital of St. Gallen
Cohort Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Early and Remitting Relapsing Multiple Sclerosis
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.
研究概览
研究类型
观察性的
注册 (预期的)
65
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Saint Gallen、瑞士、9007
- Cantonal Hospital of Saint Gallen
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
MS-Patients will be recruited in the outpatient clinic of the neurology department of the cantonal hospital of Saint Gallen, responsible for treatment of MS patients of Northeast Switzerland.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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clinically isolated syndrome
In this study the term clinically isolated syndrome (CIS) is defined according to the Task Force on Differential Diagnosis in MS, as a monophasic presentation of neurological symptoms with suspected underlying inflammatory demyelinating disease (Miller 2008).
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remitting, relapsing MS
remitting relapsing MS according to the criteria by Poser (Poser 1983) or McDonald (McDonald 2001)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
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Multiple Sclerosis Inventory Cognition (MUSIC)
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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.
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Annual Corpus Callosum Index decrease
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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.
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次要结果测量
结果测量 |
措施说明 |
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Corpus callosum Index at baseline
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The CCI at baseline will be measured from MRI findings acquired at diagnosis of clinically isolated syndrome.
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Time to clinically definite MS
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This is the time in months then patients diagnosed with CIS go on to develop clinically definite MS (CDMS).
CDMS will be diagnosed if patients fulfill the criteria for remitting relapsing MS according to Poser (Poser 1983) or McDonald (McDonald 2001).
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The Symbol Digit Modalities Test (SDMT)
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SDMT is an easily administered brief cognitive performance tests.
This test emphasizes working memory and speed processing.
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Ratio treatment duration to disease duration
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The ratio of duration of treatment (DT) to duration of disease (DD): DT/DD.
Duration of treatment is the cumulative time of treatment with interferon-beta 1b.
Duration of disease starts from the first presentation of MS symptoms
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Murat Yildiz, MD、Cantonal Hospital Saint Gallen
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (预期的)
2011年6月1日
研究完成 (预期的)
2011年6月1日
研究注册日期
首次提交
2010年11月30日
首先提交符合 QC 标准的
2010年11月30日
首次发布 (估计)
2010年12月1日
研究记录更新
最后更新发布 (估计)
2010年12月1日
上次提交的符合 QC 标准的更新
2010年11月30日
最后验证
2010年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CogImp01
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.