Evaluation of the Impact of Lesions of the Motor and Proprioceptive Brain and Pan-medullary Pathways on Their Clinically and Electrophysiologically Assessed Function in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- association ratio between EDSS score and focal injury fraction at inclusion
研究概览
简要总结
Multiple Sclerosis (MS) is the most common acquired neurological disease leading to disability, especially ambulatory, in young adults. To date, the correlation between the number or volume of white matter lesions seen on conventional MRI and the degree of disability of patients remains low to moderate. This phenomenon is known as the "clinical-radiological paradox".
In this new project, we hypothesize that an evaluation of the corticospinal pathways including their thoracic medullary portion, as well as taking into account the severity of the lesions using quantitative MRI, will allow the investigators to refine the correlation with ambulatory disability in MS patients. We will complete the evaluation of motor pathways with those of the proprioceptive pathways also strongly involved in ambulation.
详细描述
Multiple Sclerosis (MS) is the most common acquired neurological disease leading to disability, especially ambulatory, in young adults. To date, the correlation between the number or volume of white matter lesions seen on conventional MRI and the degree of disability of patients remains low to moderate. This phenomenon is known as the "clinical-radiological paradox".
The impact of the precise localisation of focal MS lesions on certain circuits particularly involved in ambulation, such as pyramidal or proprioceptive beams, has however been little studied in imaging, mainly due to technical limitations. Indeed, such studies require the acquisition of brain and spinal cord MRI images of sufficient spatial resolution to allow the localisation of focal lesions and pathways. Several previous studies have shown encouraging results by separately studying damage to the brain or spinal cord portion of the corticospinal bundle and relating it to disability. To our knowledge, no studies have analysed the lesional involvement of the cortico-spinal bundle or the entire proprioceptive bundle from the motor cortex to the medullary cone in patients with MS.
In a preliminary study, we studied the cerebral spinal cortex and cervical spinal cord bundle using data from the PHRC 2012 EMISEP and obtained encouraging results. In particular, we have shown that the cortico-spinal pathways are very frequently affected by focal lesions in the early years of the disease and that it is already correlated with the functional consequences in patients measured clinically and in electrophysiology.
In this new project, we hypothesize that an evaluation of the corticospinal pathways including their thoracic medullary portion, as well as taking into account the severity of the lesions using quantitative MRI, will allow the investigators to refine the correlation with ambulatory disability in MS patients. We will complete the evaluation of motor pathways with those of the proprioceptive pathways also strongly involved in ambulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •More than 18 years old
- •relapsing-remitting multiple sclerosis according to Mac Donald criteria (2010)
- •EDSS score at the inclusion from 0 to 4
- •With at least 1 symptom of pyramidal injury during clinical exam
- •Written informed consent
- •Affiliated to a Health Care system
- •Healthy Volunteers:
- •More than 18 years old
- •Written informed consent
- •Affiliated to a Health Care system
排除标准
- •progressive MS ;
- •Corticoids during the last 60 days before inclusion ;
- •Other neurological disease or Other progressive systemic disease
- •adults subject to legal protection or persons deprived of liberty
- •Contraindications to MRI
- •Contraindications to motor evoked potentials
- •Current pregnancy or breast-feeding
- •Healthy volunteers:
- •History of disease affecting central nervous system
- •Familial history of MS
- •History of medullar injury
- •Spinal osteoarthritis which can lead to a spinal hypersignal ;
- •adults subject to legal protection or persons deprived of liberty
- •Contraindications to MRI
- •Contraindications to motor evoked potentials
- •Current pregnancy or breast-feeding
研究组 & 干预措施
Healthy Volunteer
干预措施: Electrophysiology (Other)
Patients
干预措施: MRI (Radiation)
Patients
干预措施: Electrophysiology (Other)
Healthy Volunteer
干预措施: MRI (Radiation)
结局指标
主要结局
association ratio between EDSS score and focal injury fraction at inclusion
时间窗: 24 months
EDSS score is a specific multiple sclerosis scale, named Expanded Disability Status Scale, from 0 (normal neurological status) to 10 (death kinked to sclerosis). Focal injury fraction is focal injury volume divided by the volume of goal zone and will be assessed by MRI analysis.
次要结局
- Correlation between focal lesion load and changes in Expanded Disability Status Scale (EDSS)(24 months)
- Correlation between the severity of lesions and changes in Timed 25-Foot Walk Test (T25W)(24 months)
- Correlation between focal lesion load and changes in Nine Hole Peg Test (9HPT)(24 months)
- Correlation between the severity of lesions and changes in Nine Hole Peg Test (9HPT)(24 months)
- Correlation between the severity of lesions and changes in Expanded Disability Status Scale (EDSS)(24 months)
- Differences in central conduction times between patients and healthy volunteers(1 day)
- Correlation between focal lesion load and changes in Timed 25-Foot Walk Test (T25W)(24 months)
- Correlation between the severity of lesions and all limbs electrophysiology parameters(24 months)
- Correlation between in focal lesion load of pathways and changes in Expanded Disability Status Scale(24 months)
- Correlation between focal lesion load and changes in walking distance(24 months)
- Correlation between the severity of lesions and changes in walking distance(24 months)
- Correlation between focal lesion load and changes in 12-Item Multiple Sclerosis Walking Scale (MSWS12) score(24 months)