Cognitive Training for the Remediation of Functional Brain Health in HIV

NCT02571504 | Completed

• 2 other identifiers: 14-367 BMDCTNPT 026
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive deficits in HIV reflect degraded brain network functioning that may be amenable to remediation through cognitive training. In this sub-study, we will make use of Plasticity-based Adaptive Cognitive Remediation (PACR), which applies well-understood techniques derived from brain plasticity and implicit/procedural/perceptual learning to improve the speed and accuracy of information processing, with exercises that are designed to drive generalized improvements. Simultaneously, these exercises heavily engage neuromodulatory systems to re-establish their normal control over learning and memory. As an individual restores these degraded abilities through intensive procedural learning, the encoding of naturalistic information significantly improves, and all resulting declarative memory and cognitive functions based on the quality of that incoming information necessarily improve as well, leading to improvement that generalizes beyond the trained tasks. A subset of 80 HIV+ individuals will undergo eight weeks of PACR to determine its feasibility and appropriateness for people with mild cognitive difficulties related to HIV infection. The results of this study are expected to be pivotal in generating data to create an optimal training program aimed at stabilizing or improving brain function in HIV infected individuals experiencing cognitive decline.

Conditions

HIV - Human Immunodeficiency Virus; Cognitive Impairment

Keywords

HIV - Human Immunodeficiency Virus; Memory; Concentration

Outcome Measures

Primary Outcomes (1)

• Brief Cognitive Ability Measure (B-CAM)

  Ruler-like measure of cognitive ability combining self-report and performance items

  3-4 months

Secondary Outcomes (2)

• Change in Brain Health Indicators

  3 months

• Perceived Deficits Questionnaire

  9 months

Study Arms (2)

Immediate cognitive training group

EXPERIMENTAL

Plasticity-based Adaptive Cognitive Remediation (PACR) is an 8 week training to improve executive functions (e.g., working memory, flexibility, cognitive control) as well as attention. Participants in the immediate cognitive training group will receive the PACR intervention shortly after enrollment.

Behavioral: Plasticity-based Adaptive Cognitive Remediation (PACR)

Waitlist control group

EXPERIMENTAL

Participants in the waitlist control group will receive a brochure with 8 simple tips for better brain health around the time of enrollment. They will begin the Plasticity-based Adaptive Cognitive Remediation (PACR) intervention within 8 weeks of the initial enrollment.

Behavioral: Plasticity-based Adaptive Cognitive Remediation (PACR)

Interventions

Plasticity-based Adaptive Cognitive Remediation (PACR) BEHAVIORAL

Web-based cognitive training program focused on improving attention and executive function (designed by Posit Science)

Immediate cognitive training group; Waitlist control group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 35 years or older;
• HIV infection for at least 1 year;
• able to communicate in English or French;
• capable of providing informed consent;
• easy access to the internet;
• EEG and MRI compatible

You may not qualify if:

• presence of dementia;
• life expectancy \< 3 y;
• other neurological disorder including active opportunistic CNS infection;
• psychotic disorder;
• current substance dependence or abuse; and
• Hepatitis C requiring interferon therapy during the study period

Sponsors & Collaborators

• McGill University: lead
• Posit Science Corporation: collaborator

Study Sites (1)

Montreal Neurological Institute and Hospital (McGill University)

Montreal, Quebec, H3A 2B4, Canada

Location

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lesley K Fellows, MD, DPhil

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: October 8, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)