Stroke Cerebral Reorganization Pathways Longitudinal Study After Stroke of the Clinical Motor Pattern and the Cerebral Reorganization According to the Different Damaged Motor Pathways (main and Accessory) (SPECTRE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in effective connectivity of Brain data (fMRI activity and CST tractography)
研究概览
简要总结
SPECTRE is a prospective longitudinal study in order to identify whether patients with different degrees of motor recovery are distinguished by distinct brain post-stroke plasticity patterns in the acute and sub-acute phases. This study allows close longitudinal follow-up of patients with severe clinical motor impairment using functional MRI to study cerebral neuroplasticity after ischemic stroke in the acute and sub-acute phase in patients with upper limb motor impairement, taking into account prognostic criteria used in current practice.
详细描述
Patients are recruited as they are admitted to the neurovascular department. The SAFE score from the Stinear study is taken on Day 3 of the stroke, followed by motor evoked potentials between Day 3-Day 7 of the stroke, for a equal distribution of patients into three prognostic groups according to the PREP2 algorithm (good, limited and poor).
Longitudinal follow-up with clinical scores and functional MRI at Day 7-Day 10, Day 30, Month 3 and Month 6 of stroke.
Patients will ultimately be classified and analyzed according to their effective motor recovery at 6 months, using the Fugl-Meyer score.
The investigators will then conduct a comprehensive analysis of brain connectivity, examining both the anatomical structure of the brain, its functional activity and the dynamic interactions between certain regions of interest over time.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age greater than or equal to 18 years) less than 75 years of age, both sexes;
- •single supratentorial ischemic stroke confirmed by brain imaging
- •Upper limb deficit defined by a SAFE score <5 (SAFE Stinear protocol, prognosis of post-stroke upper limb recovery) on D3 of stroke. This corresponds to the sum of shoulder abduction and finger extension according to the MRC (Medical Research Council) scale for each of these movements out of
- •Absence of comprehension disorders limiting participation;
- •Patient covered by french social security;
- •Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature).
- •Non-Inclusion Criteria:
- •Multiple ischemic strokes or history of clinically significant stroke ;
- •Posterior fossa stroke ;
- •Hemorrhagic stroke;
- •Patient who have undergone thrombolysis or mechanical thrombectomy;
- •Extensive Fazekas grade 3 vascular leukopathy;
- •Pre-existing neurodegenerative pathology;
- •Patient with severe dyspnea or swallowing disorders who cannot undergo brain MRI;
- •Adults under legal protection (safeguard of justice, curatorship, guardianship, family habilitation), persons deprived of liberty;
- •Women declaring that they are pregnant or breast-feeding;
- •Patient participating in another therapeutic or drug intervention study that may have an impact on the effect of cerebral neuroplasticity on the SPECTRE study;
- •Patients with contraindications to MRI pacemaker or implantable defibrillator, neurosurgical clips, cochlear implants, intra-orbital or encephalic metallic foreign bodies, stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago, claustrophobia.
排除标准
- •If the prognostic group according to the PREP2 algorithm (good, limited and poor) has already been reached during motor evoked potential assessment the patient is excluded.
- •Recurrence of clinically significant stroke (with worsening NIHSS score > 4) during study.
结局指标
主要结局
Changes in effective connectivity of Brain data (fMRI activity and CST tractography)
时间窗: 6 months
Descriptive analysis of topological measures of effective connectivity graphs as a function of effective motor recovery (Fugl-Meyer score - Upper Extremity) at 6 months. The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
次要结局
- Changes in neurological events(From enrollment to the end of evaluation at 6 months)
- Changes in Effective connectivity of brain data(From Day 7-Day 10 to 6 months)
- Changes in Structural connectivity of brain data(From Day7-Day 10 to 6 months)
- Changes in Modification of brain activity of brain data(From Day 7-Day 10 to 6 months)
- Changes in Ipsilesional / contralesional laterality index of brain data(From Day 7-Day 10 to 6 months)
- Changes in perfusion of brain data(From Day 7-Day 10 to 6 months)
- Changes in Degree of corticospinal FA ratio of brain data(From Day 7-Day 10 to 6 months)
- Changes in patients' clinical profile in quality of life(6 months)
- Changes in patients' clinical profile in independence(6 months)
- Changes in patients' clinical profile in spasticity(6 months)
- Changes in clinical profile in terms of motor skills(6 months)
- Changes in clinical profile in terms of of global impairment(6 months)
- Changes in patients' clinical profile in terms of motricity(6 months)