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Clinical Trials/NCT03279835
NCT03279835
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country86 target enrollmentMarch 16, 2017
ConditionsHIV-1

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV-1
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
86
Locations
1
Primary Endpoint
Cognitive Speed Computerized Test (CSCT) score
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 16, 2017
End Date
October 30, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Cognitive Speed Computerized Test (CSCT) score

Time Frame: at patient inclusion

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

Montreal Cognitive Assessment (MoCA) Score

Time Frame: at patient inclusion

allows the evaluation of the overall cognitive functioning

Secondary Outcomes

  • Paced Auditory Serial Addition Test (PASAT) score(at patient inclusion)
  • Verbal fluency test(at patient inclusion)
  • Numeric Memory (WAIS-III location and back)(at patient inclusion)
  • Score RL-RI16(at patient inclusion)
  • IADL score(at patient inclusion)
  • Rey figure(at patient inclusion)
  • TMTB - TMTA Time Score(at patient inclusion)

Study Sites (1)

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