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临床试验/NCT03586258
NCT03586258
招募中
不适用

Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 400 人2019年1月10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, Caen
入组人数
400
试验地点
1
主要终点
Cognitive Deficit
状态
招募中
最后更新
19天前

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/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.

注册库
clinicaltrials.gov
开始日期
2019年1月10日
结束日期
2030年6月1日
最后更新
19天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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

Brain Damaged Subjects

Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders

干预措施: Brain Imaging

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)

Healthy Volunteers

Healthy Controls

干预措施: Neuropsychological testing

Healthy Volunteers

Healthy Controls

干预措施: Brain Imaging

Healthy Volunteers

Healthy Controls

干预措施: Galvanic Vestibular Stimulation (GVS)

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.

研究点 (1)

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