Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cognitive Deficit
研究概览
简要总结
Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects.
The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.
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
- •Age > 17 years
- •French language
- •Effective contraception for women during the study
- •Informed consent
- •No alcohol intake the day before the exam
- •For patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology, developmental or degenerative disease with cognitive deficit
排除标准
- •For healthy volunteers: previous neurological history (except non complicated migraine or epilepsy), previous psychiatric history (except depression with good evolution or anxiety), or severe cranial traumatism
- •For patients: vigilance disorders, severe depression or anxiety.
- •For both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for MRI or GVS if applicable, participation in another trial or former involvement in another trial within one month.
研究组 & 干预措施
Brain Damaged Subjects
Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders
干预措施: Neuropsychological testing (Behavioral)
Brain Damaged Subjects
Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders
干预措施: Brain Imaging (Other)
Brain Damaged Subjects
Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders
干预措施: Galvanic Vestibular Stimulation (GVS) (Other)
Healthy Volunteers
Healthy Controls
干预措施: Neuropsychological testing (Behavioral)
Healthy Volunteers
Healthy Controls
干预措施: Brain Imaging (Other)
Healthy Volunteers
Healthy Controls
干预措施: Galvanic Vestibular Stimulation (GVS) (Other)
结局指标
主要结局
Cognitive Deficit
时间窗: 3 months to more than 2 years
The cognitive deficit of interest will depend on the localization of the brain lesion. The outcome measure could be a standardized neuropsychological test or an experimental test specifically elaborated for this protocol.
次要结局
未报告次要终点