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Completed

NCT Number: NCT03279835

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pasteur 2 - Service de Neurologie

Nice, 06001, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Classic evaluation of neurocognitive functions

Other

Symbol Digit Modalities Test (SDMT)

New evaluation of neurocognitive functions

Other

Cognitive Speed Computerized Test (CSCT)

Primary outcomes

  1. Cognitive Speed Computerized Test (CSCT) score

    Time frame: at patient inclusion

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

  2. Montreal Cognitive Assessment (MoCA) Score

    Time frame: at patient inclusion

    allows the evaluation of the overall cognitive functioning

Secondary outcomes

  1. Paced Auditory Serial Addition Test (PASAT) score

    Time frame: at patient inclusion

    allows to evaluate the concentration capacity

  2. Numeric Memory (WAIS-III location and back)

    Time frame: at patient inclusion

    short-term memory evaluation and verbal working memory

  3. Score RL-RI16

    Time frame: at patient inclusion

    allows the evaluation of episodic and long-term verbal memory

  4. Rey figure

    Time frame: at patient inclusion

    allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning

  5. TMTB - TMTA Time Score

    Time frame: at patient inclusion

    Assessment of Mental Flexibility

  6. Verbal fluency test

    Time frame: at patient inclusion

    allows the evaluation of the verbal initiation and verbal language capacities

  7. IADL score

    Time frame: at patient inclusion

    allows to evaluate the symptomatic character of the disorders

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: NEURACog

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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