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

NCT03279835 | Completed

• 1 other identifier: 16-PP-09
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 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.

Conditions

HIV-1

Outcome Measures

Primary Outcomes (2)

• Cognitive Speed Computerized Test (CSCT) score

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

  at patient inclusion

• Montreal Cognitive Assessment (MoCA) Score

  allows the evaluation of the overall cognitive functioning

  at patient inclusion

Secondary Outcomes (7)

• Paced Auditory Serial Addition Test (PASAT) score

  at patient inclusion

• Numeric Memory (WAIS-III location and back)

  at patient inclusion

• Score RL-RI16

  at patient inclusion

• Rey figure

  at patient inclusion

• TMTB - TMTA Time Score

  at patient inclusion

Study Arms (4)

Absence of cognitive disorder

Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions

Asymptomatic cognitive disorder

Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions

Symptomatic cognitive impairment

Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions

HIV associated dementia

Other: Classic evaluation of neurocognitive functions; Other: New evaluation of neurocognitive functions

Interventions

Classic evaluation of neurocognitive functions OTHER

Symbol Digit Modalities Test (SDMT)

Absence of cognitive disorder; Asymptomatic cognitive disorder; HIV associated dementia; Symptomatic cognitive impairment

New evaluation of neurocognitive functions OTHER

Cognitive Speed Computerized Test (CSCT)

Absence of cognitive disorder; Asymptomatic cognitive disorder; HIV associated dementia; Symptomatic cognitive impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients infected with HIV-1

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital Pasteur 2 - Service de Neurologie

Nice, 06001, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: March 16, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

FR (1)