Clinical trial NCT03279835: Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients
Official title: Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected with HIV-1

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Speed Computerized Test (CSCT) score
timeFrame: at patient inclusion
measure: Montreal Cognitive Assessment (MoCA) Score
timeFrame: at patient inclusion
Secondary outcomes:
measure: Paced Auditory Serial Addition Test (PASAT) score
timeFrame: at patient inclusion
measure: Numeric Memory (WAIS-III location and back)
timeFrame: at patient inclusion
measure: Score RL-RI16
timeFrame: at patient inclusion
measure: Rey figure
timeFrame: at patient inclusion
measure: TMTB - TMTA Time Score
timeFrame: at patient inclusion
measure: Verbal fluency test
timeFrame: at patient inclusion
measure: IADL score
timeFrame: at patient inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur 2 - Service de Neurologie
Study officials:
References: