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

NCT ID: NCT03279835

Last Updated: 2019-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-16

Study Completion Date

2018-10-30

Brief Summary

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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

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Conditions

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HIV-1

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Absence of cognitive disorder

Classic evaluation of neurocognitive functions

Intervention Type OTHER

Symbol Digit Modalities Test (SDMT)

New evaluation of neurocognitive functions

Intervention Type OTHER

Cognitive Speed Computerized Test (CSCT)

Asymptomatic cognitive disorder

Classic evaluation of neurocognitive functions

Intervention Type OTHER

Symbol Digit Modalities Test (SDMT)

New evaluation of neurocognitive functions

Intervention Type OTHER

Cognitive Speed Computerized Test (CSCT)

Symptomatic cognitive impairment

Classic evaluation of neurocognitive functions

Intervention Type OTHER

Symbol Digit Modalities Test (SDMT)

New evaluation of neurocognitive functions

Intervention Type OTHER

Cognitive Speed Computerized Test (CSCT)

HIV associated dementia

Classic evaluation of neurocognitive functions

Intervention Type OTHER

Symbol Digit Modalities Test (SDMT)

New evaluation of neurocognitive functions

Intervention Type OTHER

Cognitive Speed Computerized Test (CSCT)

Interventions

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Classic evaluation of neurocognitive functions

Symbol Digit Modalities Test (SDMT)

Intervention Type OTHER

New evaluation of neurocognitive functions

Cognitive Speed Computerized Test (CSCT)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Pasteur 2 - Service de Neurologie

Nice, , France

Site Status

Countries

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France

Other Identifiers

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16-PP-09

Identifier Type: -

Identifier Source: org_study_id

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