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

Completed

• Conditions: HIV-1
• Interventions: Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions

• Registration Number: NCT03279835
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Absence of cognitive disorder	New evaluation of neurocognitive functions	-
Asymptomatic cognitive disorder	New evaluation of neurocognitive functions	-
Absence of cognitive disorder	Classic evaluation of neurocognitive functions	-
Asymptomatic cognitive disorder	Classic evaluation of neurocognitive functions	-
Symptomatic cognitive impairment	Classic evaluation of neurocognitive functions	-
Symptomatic cognitive impairment	New evaluation of neurocognitive functions	-
HIV associated dementia	Classic evaluation of neurocognitive functions	-
HIV associated dementia	New evaluation of neurocognitive functions	-

Primary Outcome Measures

Name	Time	Method
Cognitive Speed Computerized Test (CSCT) score	at patient inclusion	allows the evaluation of the speed of the processing of the information
Montreal Cognitive Assessment (MoCA) Score	at patient inclusion	allows the evaluation of the overall cognitive functioning

Secondary Outcome Measures

Name	Time	Method
Paced Auditory Serial Addition Test (PASAT) score	at patient inclusion	allows to evaluate the concentration capacity
Verbal fluency test	at patient inclusion	allows the evaluation of the verbal initiation and verbal language capacities
Numeric Memory (WAIS-III location and back)	at patient inclusion	short-term memory evaluation and verbal working memory
Score RL-RI16	at patient inclusion	allows the evaluation of episodic and long-term verbal memory
IADL score	at patient inclusion	allows to evaluate the symptomatic character of the disorders
Rey figure	at patient inclusion	allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning
TMTB - TMTA Time Score	at patient inclusion	Assessment of Mental Flexibility

Trial Locations

Locations (1)

Hôpital Pasteur 2 - Service de Neurologie; 🇫🇷 Nice, France