Teleneuropsychological Intervention in Asymptomatic HIV Seropositive Patients: N&C NeuroChange

Summary

Currently 37.9 million people are living with human immunodeficiency virus (HIV) around the world (UNAIDS, 2018). Even with antiretroviral treatment (ART), the virus enters the central nervous system and can affect the following structures: amygdala, hippocampus, thalamus, parietal, frontal, temporal regions, orbitofrontal, cingulate, motor and sensory cortex; generating cognitive, behavioral and motor alterations, up to HIV-associated neurocognitive disorder (HAND) and occasionally HIV-associated dementia (HAD).

Few clinical studies have been conducted using computerized cognitive rehabilitation programs to counteract neuropsychological alterations. The aim of this project is to explore the feasibility of a cognitive stimulation program (CSP) developed to strengthen cognitive domains identified as impaired through a neuropsychological assessment in asymptomatic HIV+ patients adherent to ART, with the purpose of improving their quality of life and mood disorder.

Conditions

• Telerehabilitation
• Neuropsychology
• HIV Dementia

Interventions

BEHAVIORAL

Cognitive stimulation program

The cognitive stimulation program consists of 12 sessions of approximately 45 minutes, distributed in a first stage of training and psychoeducation (1 session), a second stage to address emotional aspects of anxiety and depression (2 sessions), and neuropsychological training (8 sessions) and a final closing stage with one session. There will be two sessions per week for 6 weeks. The neuropsychological training includes 20 activities whose level of difficulty will vary according to the number of stimuli and the time of stimuli presentation. It includes 5 attentional activities, 3 memory activities, 5 executive functioning activities, one visuospatial skills activity and 6 ecological activities. These activities will be developed on a digital computer platform where patients will be assigned an identification and password to ensure confidentiality.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico

  lead OTHER

Principal Investigators

• Natalia C Cortés, MD · Universidad Nacional Autonoma de Mexico

• Ma Guillermina T Yáñez, PhD · Universidad Nacional Autonoma de Mexico

• Dulce María Bélen C Prieto, PhD · Universidad Nacional Autonoma de Mexico

• Edgar R Landa, PhD · Universidad Nacional Autonoma de Mexico

• Juan C Castillo, PhD · National Polythecnic Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-16

Primary Completion

2023-11-28

Completion

2024-05-30

Countries

• Mexico

Study Locations