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临床试验/NCT01250678
NCT01250678Unknown不适用

Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab

Cantonal Hospital of St. Gallen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
The Symbol Digit Modalities Test (SDMT)

研究概览

简要总结

Cognitive impairment is seen in about half of patients with relapsing remitting MS. Our knowledge about long term development of cognitive performance under natalizumab therapy is limited. We want to demonstrate with this study that patients treated with ntz improve in neurocognitive tests over the long term.

详细描述

Impaired cognitive function may represent damage to brain regions that are not involved in physical functions, hence may not be detected during routine neurological assessment. Despite the high prevalence of cognitive impairment in MS, cognitive function is not assessed routinely in clinical practice. The perception that cognitive assessments are costly, time-consuming, complicated, and difficult to administer and interpret has contributed, at least in part, to the failure to incorporate cognitive testing into standard clinical evaluation of patients with MS.

Cognitive impairment may also reduce the ability of patients to comprehend and adhere to treatment concepts (Bobholz 2003). Early detection of cognitive impairment is important to initiate therapeutic intervention, even though the optimal treatment of cognitive decline in MS is at the moment controversial.

Preliminary studies suggest an essential role of disease modifying therapies (DMT) in inhibition of cognitive deterioration in patients with MS (Barak 2002, Flechter 2007). Data about long term cognitive performance of multiple sclerosis patients treated with natalizumab is limited. One study demonstrated in MS patients treated with natalizumab an improvement in SDMT (Symbol Digit Modalities Test) of 16.4% over a period of 2 years (Piehl 2010). SDMT is a screening tool for cognitive impairment in MS patients, mainly measuring working memory and speed processing. As SDMT only covers a part of the neurocognitive impairments seen in MS patients, there is a need for further studies to gain a more complete picture.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 and 55 years at presentation
  • Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005
  • Patients treated with ntz
  • 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

The Symbol Digit Modalities Test (SDMT)

时间窗: 3 years

SDMT is an easily administered brief screening tool for cognitive dysfunction in MS. Patients view a key presenting nine numbers paired with symbols. Below the key is an array of symbols paired with empty spaces, the patient's task being to voice the matching number for each symbol as rapidly as possible.

次要结局

  • Multiple Sclerosis Inventory Cognition (MUSIC)(3 years)
  • TAP subtest Alertness(3 years)
  • Composite neurocognitive index(3 years)

研究者

申办方类型
Other

研究点 (1)

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