The Targeted Neurocognitive Training (TNT) Study

NCT05773430 | Suspended

• 2 other identifiers: IRB-300010567UAB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

People with HIV (PWH) often suffer from cognitive impairments known as HIV-Associated Neurocognitive Disorder (HAND). Cognitive impairments in PWH are not fully captured by traditional neurocognitive assessment; thus, we must examine cognitive performance both within a task (inconsistency) and across cognitive domains (dispersion), called Intra-Individual Variability (IIV). IIV predicts cognitive impairment/decline, altered brain morphology, and neuropathology in many clinical populations. Conceptually, IIV results from "executive dyscontrol" or the efficiency (or inefficiency) with which executive control processes coordinate other cognitive processes/domains. Based on the Executive Dyscontrol Hypothesis and underlying calculations of IIV, one way to improve cognition in PWH is through interventions that target improvements in their most severely impaired cognitive domains. We hypothesize such improvements, in turn, should reduce the strain placed on executive functioning resources, freeing up resources needed to compensate for impairments in any domain and, in turn, reducing IIV. Computerized cognitive training, widely used in the study team's prior work, is ideally suited to target impairments in select cognitive domains using computerized cognitive training. In our systematic review of 13 cognitive training studies in PWH, we found cognitive training improved performance in the targeted domain. In this feasibility study, we will assess 150 PWH at baseline with the expectation to recruit 120 PWH with HAND. Then we will use a two-group pre-post experimental design of 120 adults with HAND including: 1) a Targeted Neurocognitive Training (TNT) group (n=60) to train each participant's two most impaired cognitive domains (e.g., attention \& memory) assessed from a neurocognitive battery at baseline, and 2) a no-contact control group (n=60). Aim 1 - Feasibility: To determine feasibility and acceptability of the intervention. Exploratory Aim 1 - Cognition: Compare adults who receive TNT to those who receive no training to determine whether they improve on the cognitive domains trained, show less cognitive IIV across domains and within a task, and demonstrate improved executive functioning. Exploratory Hypothesis 1: TNT will improve cognitive functioning in the targeted impaired cognitive domains. Exploratory Hypothesis 2: TNT will reduce cognitive IIV (both overall dispersion \& inconsistency). Exploratory Hypothesis 3: TNT will improve executive functioning. Exploratory Hypothesis 4: TNT will improve global cognition and reduce HAND severity. Innovation 1 - This is the first study to use IIV to guide cognitive training to target the most impaired cognitive domains to reduce cognitive IIV in HIV. Innovation 2 - This will be one of the first studies to prospectively include both types of cognitive IIV - dispersion and inconsistency - allowing us to examine the relationship between dispersion and inconsistency. Innovation 3 - The epicenter of HIV is in the Deep South where this study will occur.

Conditions

HIV; Aging; Cognitive Function Abnormal; Cognitive Training; Older Adults

Keywords

HIV-Associated Neurocognitive Disorder; cognitive training; executive dysfunction; feasibility

Outcome Measures

Primary Outcomes (5)

• Baseline Assessment of Cognitive Training

  All participants at baseline will be asked questions about computer use, knowledge about cognitive training, their perceptions about whether they need cognitive training, knowledge about HIV and cognition, etc. Both quantitative and qualitative (i.e., open-ended responses) data will be collected; this is similar to our other studies

  ~12 weeks

• Cognitive Training Satisfaction Questionnaire

  Used to assess likes/dislikes of the intervention, both quantitative questions and qualitative (i.e., open-ended responses) data are gathered as has been used in our previous cognitive intervention studies to evaluate feasibility and acceptability.

  ~12 weeks

• Exit Survey

  Investigators will administer a brief quantitative and qualitative (i.e., open-ended responses) survey to assess what he/she liked/disliked about the training and how to improve it.

  ~12 weeks

• Adherence Rates (after study data collection)

  Investigators will calculate the adherence rate of the protocol, similar to the investigator's other studies. Ranges will be from 0% to 100%.

  Through study completion, an average of 2 years

• Attrition Rates (after study data collection)

  Investigators will calculate the attrition rate of the protocol, similar to the investigator's other studies. Ranges will be from 0% to 100%.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning)

  ~12 weeks

Study Arms (2)

Targeted Neurocognitive Training

EXPERIMENTAL

BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on the two cognitive domains in which the participants exhibited the worst performance at baseline. Twenty hours or training will administer to each participant target these two cognitive domains (10 hours each). These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.

Behavioral: Targeted Neurocognitive Training

No-Contact Control Group

NO INTERVENTION

These participants will not receive any intervention.

Interventions

Targeted Neurocognitive Training BEHAVIORAL

Only two cognitive domains will be targeted for training (10 hrs of training in each, for a total of 20 hours). Two or more cognitive exercises may be employed within a cognitive domain. These exercises provide both immediate and intermittent feedback and are customized to the participants' individual ability; the difficulty and/or complexity of each game are systematically decreased/increased based on participants' performance to always be challenging, but not overly frustrating. Typically, in an hour session, one exercise (e.g., Mental Map) will be engaged at a time (20-30 minutes) before switching to another exercise (e.g., Hawkeye) in another domain for 20-30 minutes. This helps the participant remain engaged but avoid fatigue.

Targeted Neurocognitive Training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants (men \& women) must be 40+ years
• English speaking,
• Have HIV-Associated Neurocognitive Disorder (HAND)
• Willing to meet in person
• Has time to participate for \~12 weeks

You may not qualify if:

• Participants living beyond 60 miles away from the center
• Participants living in unstable housing (e.g., halfway house)
• Participants with significant neuromedical comorbidities (e.g., schizophrenia)
• Participants with other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma, diagnosed with COVID-19 over the past 3 months) that could impact cognitive functioning or testing.
• Participants who have received cognitive training within the past three years- -

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Vance DE, Fazeli PL, Cheatwood J, Nicholson C, Morrison S, Moneyham LD. Targeting HIV-Related Neurocognitive Impairments with Cognitive Training Strategies: Insights from the Cognitive Aging Literature. Curr Top Behav Neurosci. 2021;50:503-515. doi: 10.1007/7854_2018_80.

  PMID: 30710223 BACKGROUND

• Vance DE, Fazeli PL, Azuero A, Wadley VG, Raper JL, Ball KK. Can Individualized-Targeted Computerized Cognitive Training Benefit Adults with HIV-Associated Neurocognitive Disorder? The Training on Purpose Study (TOPS). AIDS Behav. 2021 Dec;25(12):3898-3908. doi: 10.1007/s10461-021-03230-y. Epub 2021 Mar 18.

  PMID: 33733311 BACKGROUND

• Waldrop D, Irwin C, Nicholson WC, Lee CA, Webel A, Fazeli PL, Vance DE. The Intersection of Cognitive Ability and HIV: A Review of the State of the Nursing Science. J Assoc Nurses AIDS Care. 2021 May-Jun 01;32(3):306-321. doi: 10.1097/JNC.0000000000000232.

  PMID: 33449578 BACKGROUND

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Testers will be unaware of which training condition participants are assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A pre-post two-group experimental design will be used. One group will receive the experimental targeted neurocognitive training and the other group will not receive anything (no-contact control group)

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon completion of the study
• Access Criteria: Based upon IRB approval and Data Use Agreement

Locations

US (1)