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

HIV-1 Clinical Trial

— NEURACog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279835
• Other study ID #: 16-PP-09
• Status: Completed
• Start date: March 16, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• HIV-1

Intervention

Other:
• Classic evaluation of neurocognitive functions
Symbol Digit Modalities Test (SDMT)
• New evaluation of neurocognitive functions
Cognitive Speed Computerized Test (CSCT)

Locations

Country	Name	City	State
France	Hôpital Pasteur 2 - Service de Neurologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Speed Computerized Test (CSCT) score	allows the evaluation of the speed of the processing of the information	at patient inclusion
Primary	Montreal Cognitive Assessment (MoCA) Score	allows the evaluation of the overall cognitive functioning	at patient inclusion
Secondary	Paced Auditory Serial Addition Test (PASAT) score	allows to evaluate the concentration capacity	at patient inclusion
Secondary	Numeric Memory (WAIS-III location and back)	short-term memory evaluation and verbal working memory	at patient inclusion
Secondary	Score RL-RI16	allows the evaluation of episodic and long-term verbal memory	at patient inclusion
Secondary	Rey figure	allows the evaluation of the long-term capacities of visio-construction (wealth score) and planning	at patient inclusion
Secondary	TMTB - TMTA Time Score	Assessment of Mental Flexibility	at patient inclusion
Secondary	Verbal fluency test	allows the evaluation of the verbal initiation and verbal language capacities	at patient inclusion
Secondary	IADL score	allows to evaluate the symptomatic character of the disorders	at patient inclusion