Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline
研究概览
简要总结
This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.
详细描述
Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time.
The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline).
The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment.
Yearly assessment starting from study inclusion will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active MS, according to the Lublin criteria
- •disease duration < 10 years before initiating or changing a disease-modifying therapies,
- •relapse- and steroid-free for at least 1 month before MRI acquisition
- •between 18-50 years old
- •having given informed consent
- •with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances
排除标准
- •progressive forms of MS
结局指标
主要结局
evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline
时间窗: 3 years
changes from baseline in cognitive scores
baseline predictors of future cognitive impairment
时间窗: 3 years
abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)
Predictors of disease evolution
时间窗: 3 years
EDSS score worsening from baseline
次要结局
- predictive role of mEPS in predicting future disability(3 years)
- alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment(3 years)
研究者
Frédéric London
Principal Investigator
University Hospital of Mont-Godinne