Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
研究概览
简要总结
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
详细描述
This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients:
- •Men and Women
- •≥16 years
- •Fluent French speaker
- •Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation
- •Between 60 and 180 days from the onset
- •At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of at least 3 mm, at least one of which being cerebral, ovoid, or periventricular
- •Having a medical insurance
- •Free and informed consent signed
- •Controls:
- •Men and Women
- •≥18 years
- •Fluent French speaker
- •Having a medical insurance
- •Free and informed consent signed
排除标准
- •Patients:
- •Prior documented neurological episode suggestive of MS.
- •Other ongoing neurological diseases.
- •Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, sclerodermia, Crohn disease,...).
- •Other causes (trauma, tumor, radiotherapy, infections, vascular diseases, neuromyelitis optica).
- •Current dependence on alcohol or drugs.
- •Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 15 days
- •MRI contra-indications.
- •Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
- •Controls:
- •Known chronic psychiatric or neurologic diseases which could interfere with neuropsychological testing, not taking into account stable and mild depressive syndrome
- •Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, scleroderma, Crohn disease...).
- •MS familial history
- •Current dependence on alcohol or drugs
- •Known cognitive impairment
- •Prior neuropsychological testing with the same tests less than one year
- •Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 2 months
- •Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
- •MRI contra-indications
- •Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
研究组 & 干预措施
Control
healthy subject
干预措施: Eye movement (Other)
Patient
Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation
干预措施: Brain MRI - Clinical and cognitive evaluation (Other)
Patient
Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation
干预措施: Eye movement (Other)
Control
healthy subject
干预措施: Brain MRI - Clinical and cognitive evaluation (Other)
结局指标
主要结局
Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains
时间窗: visit 2 - 1 year after inclusion
IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients
次要结局
- Comparison of cognitive scores at each test between CIS patients and controls(D0 and V2 - 1 year after the inclusion)
- Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue(D0 and V2 - 1 year after the inclusion)
- Comparison of skeleton of FA between CIS patients and healthy subjects(V2 - 1 year after the inclusion)
- Comparison of statistical maps of FA(D0 and V2 - 1 year after the inclusion)
- Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients(D0 and V2 - 1 year after the inclusion)
- Comparison of cognitive scores at each test and eye movements scores(D0 and V2 - 1 year after the inclusion)