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临床试验/NCT01849549
NCT01849549
已完成
不适用

Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 346 人2013年5月1日

概览

阶段
不适用
干预措施
Neuropsychological testing
疾病 / 适应症
Cerebrovascular Disorders
发起方
University Hospital, Rouen
入组人数
346
试验地点
1
主要终点
Cognitive deficit
状态
已完成
最后更新
2个月前

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 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) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

注册库
clinicaltrials.gov
开始日期
2013年5月1日
结束日期
2022年3月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Rouen
责任方
Sponsor

入排标准

入选标准

  • age between 18 and 80 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 or degenerative disease with cognitive deficit

排除标准

  • for healthy volunteers: previous neurological history (except non complicated migraine), previous psychiatric history (except depression with good evolution or anxiety with maximum one anxiolytic treatment), 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, 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, selective disorders of cognitive development or degenerative disorders responsible for focal troubles

干预措施: Neuropsychological testing

brain damaged subjects

patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles

干预措施: MRI

healthy volunteers

healthy controls

干预措施: Neuropsychological testing

healthy volunteers

healthy controls

干预措施: MRI

结局指标

主要结局

Cognitive deficit

时间窗: 3 to 6 months

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.

研究点 (1)

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