Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients (NEURACog)
2019年5月17日 更新者：Centre Hospitalier Universitaire de Nice
The objective of this prospective study is to evaluate the prevalence of neurocognitive impairments in HIV infected patients comparing patients with and without HAART.
Recent studies have demonstrated a specific HIV infected patients neurocognitive disorders profile.
These cognitive disorders concern primarily information processing speed, memory recall, attentional abilities, work related memory, executive functions, and psychometrical speed.
This cognitive profile is similar to another highly documented one, described for another central nervous system disease (CNS): multiple sclerosis.
In both CNS diseases, the earliest and most severe disorder is the one related to the information processing speed.
For the multiple sclerosis patients, a short cognitive test (SDMT) is actually used not only to identify cognitive disorders presence, but also in order to predict a long term disability worsening.
A digital version of this test (CSCT), has recently been developed in order to make this early evaluation easier.
We hypothesize that CSCT alteration would also predict HAND, in HIV infected patients.
A complete neuropsychological assessment is highly time and personal consuming.
This short (approximatively 2 minutes) digital test would be highly helpful to identify patients, who will need a more extensive neuropsychological assessment.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
86
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Nice、法国、06001
- Hôpital Pasteur 2 - Service de Neurologie
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients infected with HIV-1
描述
Inclusion Criteria:
- Patients infected with HIV-1
- Patients followed in outpatient service, over 18 years of age
Exclusion Criteria:
- Patients infected with HIV-2
- Patients with difficulty understanding the French language
- Patients present with progressive opportunistic infection
- Patients for whom a change of psychotropic treatment was performed in the last 3 weeks
- Patients with drug and / or alcohol addiction
- Patients with a history of psychiatric disorder
- Patients with stroke, endocarditis or meningoencephalitis with severe neurological sequelae
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Absence of cognitive disorder
|
Symbol Digit Modalities Test (SDMT)
Cognitive Speed Computerized Test (CSCT)
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Asymptomatic cognitive disorder
|
Symbol Digit Modalities Test (SDMT)
Cognitive Speed Computerized Test (CSCT)
|
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Symptomatic cognitive impairment
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Symbol Digit Modalities Test (SDMT)
Cognitive Speed Computerized Test (CSCT)
|
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HIV associated dementia
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Symbol Digit Modalities Test (SDMT)
Cognitive Speed Computerized Test (CSCT)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cognitive Speed Computerized Test (CSCT) score
大体时间：at patient inclusion
|
allows the evaluation of the speed of the processing of the information
|
at patient inclusion
|
|
Montreal Cognitive Assessment (MoCA) Score
大体时间：at patient inclusion
|
allows the evaluation of the overall cognitive functioning
|
at patient inclusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Paced Auditory Serial Addition Test (PASAT) score
大体时间：at patient inclusion
|
allows to evaluate the concentration capacity
|
at patient inclusion
|
|
Numeric Memory (WAIS-III location and back)
大体时间：at patient inclusion
|
short-term memory evaluation and verbal working memory
|
at patient inclusion
|
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Score RL-RI16
大体时间：at patient inclusion
|
allows the evaluation of episodic and long-term verbal memory
|
at patient inclusion
|
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Rey figure
大体时间：at patient inclusion
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allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning
|
at patient inclusion
|
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TMTB - TMTA Time Score
大体时间：at patient inclusion
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Assessment of Mental Flexibility
|
at patient inclusion
|
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Verbal fluency test
大体时间：at patient inclusion
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allows the evaluation of the verbal initiation and verbal language capacities
|
at patient inclusion
|
|
IADL score
大体时间：at patient inclusion
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allows to evaluate the symptomatic character of the disorders
|
at patient inclusion
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月16日
初级完成 (实际的)
2018年10月30日
研究完成 (实际的)
2018年10月30日
研究注册日期
首次提交
2017年9月7日
首先提交符合 QC 标准的
2017年9月11日
首次发布 (实际的)
2017年9月12日
研究记录更新
最后更新发布 (实际的)
2019年5月20日
上次提交的符合 QC 标准的更新
2019年5月17日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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