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临床试验/NCT02810314
NCT02810314Unknown不适用

Study of Default Mode Network (DMN) on Patients With Multiple Sclerosis (MS)

Hospital General Universitario Gregorio Marañon2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
64
试验地点
2
主要终点
Change of functional connectivity of default mode network (DMN)

研究概览

简要总结

The study will evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, investigators will include patients with progressive evolution as well as initial forms of the disease (CIS) and properly established forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs.

详细描述

To date, no clear consensus has been reached related to default mode network (DMN) activity and different clinical types of MS. Due to this controversy on the literature regarding increment and decrement of DMN activity along the natural history of MS evolution, this study aim to add experimental information and more data that might help to disentangle this paradox, also correlating this DMN activity with anatomic and cognitive indexes. The investigators will also introduce a novel experimental design, including a prospective measure of the investigators connectivity and cognitive measures.

In this study, investigators aim to evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, patients with progressive evolution as well as initial forms of the disease (CIS) will be included and properly established forms of MS in RR forms. Researchers will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs. Nevertheless, investigators consider that the study of connectivity is worth regardless their pharmacological treatment.

The investigators also aim to offer data on the natural history of MS evolution for distinct MS type patients and healthy controls, as this study is planned to collect data longitudinally.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • MS diagnostic following McDonald 2010 diagnosis criteria.
  • 18 to 60 years old.
  • Consent form signature.

排除标准

  • Dementia diagnosis, following Spanish Neurological Society criteria.
  • Mayor psychiatric illness.
  • Physical or intellectual limitations to successfully perform - neuropsychological evaluation.
  • Any other circumstance that may interfere with functional magnetic resonance session.
  • Abnormal renal function previous to magnetic resonance image (MRI) session.

结局指标

主要结局

Change of functional connectivity of default mode network (DMN)

时间窗: at study entry and after 12 months

measure is taken with fMRI

次要结局

  • Correlate grey matter indexes and cognitive functioning indexes(at study entry and after 12 months)
  • Correlate grey matter indexes and emotional/behavioural indexes(at study entry and after 12 months)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

María Luisa Martinez Gines

neurologist

Hospital General Universitario Gregorio Marañon

研究点 (2)

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