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临床试验/NCT01899924
NCT01899924已完成不适用

Cognitive Assessment of Patients With Brain Injuries by the Mean of Event

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
320
试验地点
2
主要终点
Cognitive processing assessment

研究概览

简要总结

The main objective of this study is to describe differential cognitive processing of various stimuli by a population of control subjects and a population of patients with selective cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and high-density EEG picked up system.

详细描述

In order to test the relevance of theoretical models of cognitive functions, examination of patients with cerebral lesions is of great interest. Thus, the goal of this study is to assess cognitive processing in patients by a combination of behavioural clinical tests and ERP (event related potentials) specific markers. Indeed, ERP technique makes it possible to ascertain that a patient or control subject has or has not performed the task we asked him to even if the subject performs the task covertly. From these ERPs markers, we can investigate their respective cortical generators. By comparing the results obtained in both healthy and pathological populations, we will be able to appreciate differential processing of the same stimuli by two different populations and try to correlate these differences with specific cerebral lesions and with different outcomes.We previously demonstrated the relevance of this approach in the field of disorders of consciousness patients and we project to enrich this specific approach by the addition of new markers and by its extension to other fields of cognitive and behavioural neurology.

The procedure will be the following. After obtaining written informed consent, patients will be examined clinically with dedicated specialized scales (for example the CRS-R for disorders of consciousness patients). Then, we will probe event related potentials by stimulating these patients with various stimuli embedded in well-designed paradigms while their scalp EEG will be recorded. Following different steps of signal processing the mean ERPs according to conditions will be extracted and statistical analysis will be performed. At one year from the recording, outcome will be collected and correlated with the obtained ERPs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Control subjects
  • Inclusion Criteria:
  • adults between 18 and 80,
  • written informed consent obtained from the subject,
  • covers by social insurance,
  • absence of psychoactive drug intake in the week preceding the examination or alcohol intake the day before the exam

排除标准

  • pregnant patients or breastfeeding,
  • sensory deficit incompatible with the participation in tne study,
  • person under a legal protection measure, under guardianship,
  • psychoactive drug intake in the week preceding the examination or alcohol intake the day before the exam
  • Inclusion Criteria:
  • adults between 18 and 80,
  • written informed consent obtained from the patient or his relatives,
  • covers by social insurance,
  • patients with either focal or diffuse brain damage drom trauma, vascular, tumor or other aetiologies, or with a history of neonatal or congenital diseases,
  • patients with selective cognitive disorders or with altered states of consciousness
  • Exclusion Criteria:
  • Pregnant patients or breastfeeding,
  • sensory deficit incompatible with the participation in the study

研究组 & 干预措施

Event Related Potentials

Experimental

干预措施: Event Related Potentials recording (Behavioral)

结局指标

主要结局

Cognitive processing assessment

时间窗: Day1

Specific Event Related Potential (ERP) presence. ERP measurements indicate if a patient or control subject has or has not performed the task we asked him to even if the subject performs the task covertly

次要结局

  • Scalp topographies of ERPs(Day 1)
  • Cognitive assessment by means of specialized scales(Day1, Day 356)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

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