FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Decrease of cortical thickness
研究概览
简要总结
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.
The patient is compared to himself between day zero to ten and three months.
The study hypotheses are:
- A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).
- This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.
- This atrophy is correlated with disability at three months, assessed by Rankin score.
详细描述
Twenty-two patients with ischemic stroke, subcortical, involving the internal capsule, will be included.
Each patient will be compared to himself, on day zero to ten and three months.
An MRI will be performed between day zero and ten, then three months of infarction sequences with traditional threeD enabling acquisition and tractography and The measurement of cortical thickness is in mm The measurement of fractional anisotropy of the pyramidal tract A clinical evaluation will be done between Day zero and Day ten then three months, using a neurological score (NIHSS), a score of functional disability (Rankin) and more analytical and sensitive tests such as dynamometer, the Finger Tapping test and test new plugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 18 to 90 years old.
- •Subcortical stroke
- •Achievement of the internal capsule, according to MRI
- •Ability to perform MRI within 10 days after the onset of symptoms
- •NIHSS over or equal 2 and < 20
- •Rankin Score over or equal 1 and ≤ 5
- •Written informed consent after information about the protocol, from patients or reliable person if patient is in incapacity to sign
- •Affiliation to a social security scheme
排除标准
- •Pregnant or nursing women
- •Other cerebral lesion, concomitant or preexisting
- •Concomitant disease causing unfavorable prognosis within 3 months after inclusion
- •pre-existing psychiatric illness
- •Alcoholism or other chronic intoxication
- •Cortical localization of the infarction
- •Patient in a coma, who cannot be examined and evaluated
- •Patient intubated, ventilated, sedated
- •Cerebral hemorrhage, intra-parenchymal and / or subarachnoid
- •Persons protected by law (guardianship, curators and judicial protection)
- •Contraindications to magnetic resonance examination: pacemaker, metal implants, neurostimulators, Clips neurosurgical wire sutures, staples, metal heart valves, ventricular bypass valve, metal workers, foreign eye, shrapnel, bullet , cochlear implants
结局指标
主要结局
Decrease of cortical thickness
时间窗: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.
Decrease of cortical thickness in the ipsilateral primary motor area, after infarction of corticospinal tract at 3 months.
次要结局
- Calculation of fractional anisotropy(3 months after infarction of corticospinal tract)
- Disability(at 3 months)