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

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ClinicalTrials.gov Identifier: NCT03279835
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV-1 Other: Classic evaluation of neurocognitive functions Other: New evaluation of neurocognitive functions

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of a Short Version Computerized Test for Processing Speed to Detect Cognitive Disorders in HIV+ Patients
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : November 16, 2018
Estimated Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Absence of cognitive disorder Other: Classic evaluation of neurocognitive functions
Symbol Digit Modalities Test (SDMT)

Other: New evaluation of neurocognitive functions
Cognitive Speed Computerized Test (CSCT)

Asymptomatic cognitive disorder Other: Classic evaluation of neurocognitive functions
Symbol Digit Modalities Test (SDMT)

Other: New evaluation of neurocognitive functions
Cognitive Speed Computerized Test (CSCT)

Symptomatic cognitive impairment Other: Classic evaluation of neurocognitive functions
Symbol Digit Modalities Test (SDMT)

Other: New evaluation of neurocognitive functions
Cognitive Speed Computerized Test (CSCT)

HIV associated dementia Other: Classic evaluation of neurocognitive functions
Symbol Digit Modalities Test (SDMT)

Other: New evaluation of neurocognitive functions
Cognitive Speed Computerized Test (CSCT)




Primary Outcome Measures :
  1. Cognitive Speed Computerized Test (CSCT) score [ Time Frame: at patient inclusion ]
    allows the evaluation of the speed of the processing of the information

  2. Montreal Cognitive Assessment (MoCA) Score [ Time Frame: at patient inclusion ]
    allows the evaluation of the overall cognitive functioning


Secondary Outcome Measures :
  1. Paced Auditory Serial Addition Test (PASAT) score [ Time Frame: at patient inclusion ]
    allows to evaluate the concentration capacity

  2. Numeric Memory (WAIS-III location and back) [ Time Frame: at patient inclusion ]
    short-term memory evaluation and verbal working memory

  3. Score RL-RI16 [ Time Frame: at patient inclusion ]
    allows the evaluation of episodic and long-term verbal memory

  4. Rey figure [ Time Frame: at patient inclusion ]
    allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning

  5. TMTB - TMTA Time Score [ Time Frame: at patient inclusion ]
    Assessment of Mental Flexibility

  6. Verbal fluency test [ Time Frame: at patient inclusion ]
    allows the evaluation of the verbal initiation and verbal language capacities

  7. IADL score [ Time Frame: at patient inclusion ]
    allows to evaluate the symptomatic character of the disorders



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients infected with HIV-1
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279835


Contacts
Contact: Christine Lebrun-Frenay, PU-PH +33 (0)4.92.03.85.27 lebrun-frenay.c@chu-nice.fr

Locations
France
Hôpital Pasteur 2 - Service de Neurologie Recruiting
Nice, France, 06001
Contact: Christine Lebrun-Frenay, Pu-PH    +33 (0)4.92.03.85.27    lebrun-frenay.c@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03279835     History of Changes
Other Study ID Numbers: 16-PP-09
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders