跳至主要内容
临床试验/NCT03279835
NCT03279835已完成不适用

Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2017年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Cognitive Speed Computerized Test (CSCT) score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patients infected with HIV-1
  • Patients followed in outpatient service, over 18 years of age

排除标准

  • 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

结局指标

主要结局

Cognitive Speed Computerized Test (CSCT) score

时间窗: at patient inclusion

allows the evaluation of the speed of the processing of the information

Montreal Cognitive Assessment (MoCA) Score

时间窗: at patient inclusion

allows the evaluation of the overall cognitive functioning

次要结局

  • Paced Auditory Serial Addition Test (PASAT) score(at patient inclusion)
  • Verbal fluency test(at patient inclusion)
  • Numeric Memory (WAIS-III location and back)(at patient inclusion)
  • Score RL-RI16(at patient inclusion)
  • IADL score(at patient inclusion)
  • Rey figure(at patient inclusion)
  • TMTB - TMTA Time Score(at patient inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验