Cognitive Remediation

NCT07171450 | Recruiting DMC

• 2 other identifiers: 25-389-21K23AG086612-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if a neuroscience-based computerized cognitive remediation ("brain training") program can treat neurocognitive dysfunction (i.e., memory or thinking difficulties) that emerges in some older adults following a viral infection. The main questions it aims to answer are:

• Does computerized cognitive remediation improve cognitive performance and day-to-day functioning in older adults with postviral neurocognitive dysfunction?
• Will treatment effects be maintained over time, leading to better long term cognitive outcomes?
• Does the treatment lead to reductions in blood-based markers of inflammation as a potential mechanism of cognitive symptom improvement?
• Can the treatment be optimized and refined based on feedback from participants to improve user (patient) experience? Researchers will compare the computerized cognitive remediation program to an active computer-based control condition (alternative computer activities) to see if the computerized cognitive remediation program works to treat postviral neurocognitive dysfunction. Participation takes approximately 43-48 hours over 7 months, with most activities (40-46 hours) completed within the first 7-8 weeks, including:
• Initial intake visit: Eligibility confirmation (\~2-3 hours)
• Computer activities: About 5 hours per week for \~6 weeks (total \~30 hours) completed on a computer tablet provided by the study and loaned to participants for use during the treatment phase
• Weekly remote check-in meetings: \~30 minutes each during treatment
• Blood draws: Two sessions (before and after treatment), \~20-30 minutes each
• Three research visits: Pre-treatment, post-treatment, and 6-month follow-up (\~2-3 hours each, including assessments of cognitive, emotional, and daily functioning)

Conditions

Aging; Inflammation; Cognitive Remediation; Cognitive Dysfunction; Postviral Syndrome; Digital Medicine

Keywords

Aging; Inflammation; Cognitive Remediation; Cognitive dysfunction; Postviral Syndrome; digital medicine

Outcome Measures

Primary Outcomes (3)

• Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B

  Part B of the Trail Making Test (Trails B) is an executive functioning measure of set-shifting abilities in which the examinee must rapidly alternate between connecting numbers and letters distributed across a page. The total time (in seconds) required for the examinee to complete the task is recorded. Lower scores (in seconds) indicate better performance. Time to complete Trails B at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment Trails B performance.

  Pre-treatment and post-treatment (Week 7)

• Group Difference in Set-Shifting Abilities at 6 Months as Measured with Trails B

  Part B of the Trail Making Test (Trails B) is an executive functioning measure of set-shifting abilities in which the examinee must rapidly alternate between connecting numbers and letters distributed across a page. The total time (in seconds) required for the examinee to complete the task is recorded. Lower scores (in seconds) indicate better performance. Time to complete Trails B at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment Trails B performance.

  Pre-treatment and 6 Months

• User Experience/Interface with Computerized Cognitive Remediation Program at Post-Treatment as Measured with the System Usability Scale

  The System Usability Scale is a well-validated, 10-item, self-report questionnaire of user experience/interface (UX/ UI) with computer-based programs. Participants rate each item using a 5-point Likert-style scale with response options ranging from "Strongly Disagree" to "Strongly Agree". Total scores ranging from 0-100 are calculated using a standard equation. Higher total scores indicate better UX/UI.

  Post-Treatment (Week 7)

Secondary Outcomes (12)

• Group Difference in Inhibitory Control at Post-Treatment as Measured with the Stroop Color and Word Test

  Pre-treatment and post-treatment (Week 7)

• Group Difference in Inhibitory Control at 6 Months as Measured with the Stroop Color and Word Test

  Pre-treatment and 6 months

• Group Difference in Verbal Generativity, Initiation, and Strategy Use at Post-Treatment as Measured with the Controlled Oral Word Association Test (COWAT)

  Pre-treatment and post-treatment (Week 7)

• Group Difference in Verbal Generativity, Initiation, and Strategy Use at 6 Months as Measured with the Controlled Oral Word Association Test (COWAT)

  Pre-treatment and 6-months

• Group Difference in Attention-Related Problems at Post-Treatment as Measured with the Conners Continuous Performance Test

  Pre-treatment and post-treatment (Week 7)

Other Outcomes (1)

• Group Difference in Blood-Based Markers of Peripheral Inflammation at Post-Treatment

  Pre-treatment and post-treatment (Week 7)

Study Arms (2)

Computerized Cognitive Remediation

EXPERIMENTAL

Other: Computerized Cognitive Remediation

Active Computer-Based Control

ACTIVE COMPARATOR

Other: Alternative Computer Activities

Interventions

Alternative Computer Activities OTHER

The active control condition is carefully matched to the experimental condition in duration, computer tablet use, audiovisual stimulation, reward presentation, and interaction with study staff. It involves playing visuospatially-oriented computerized games that do not load on executive functions and watching stimulating educational videos.

Active Computer-Based Control

Computerized Cognitive Remediation OTHER

The computerized cognitive remediation intervention ("NeuroFlex") consists of a series of gamified tasks administered via computer tablet. The intervention provides both "bottom up" training to improve basic processing of sensory stimuli and "top down" training to improve executive functions. Importantly, NeuroFlex personalizes gameplay with adaptive algorithms that adjust difficulty on a trial-by-trial basis. Participants are prescribed a 30-hour dose distributed across 6 weeks. The treatment is completed remotely by the participant within their own home or other private location that is most convenient for the participant.

Also known as: NeuroFlex

Computerized Cognitive Remediation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 60 years old
• prior history of COVID-19 that was confirmed with viral testing (e.g., positive laboratory test or positive at-home rapid test)
• cognitive symptoms (e.g., memory or thinking concerns) following COVID- 19 infection that have lasted for at least 12 weeks and are still present
• clinically meaningfully subjective cognitive concerns (i.e., T-score \< 40) on the PROMIS-Cognitive Function Scale
• fluent in English language
• off psychiatric medication or on a stable dose for at least 8 weeks

You may not qualify if:

• history of neurological disorder with potential to interfere with study participation or confound results (e.g., uncontrolled seizure disorder, moderate to severe traumatic brain injury or stroke with persistent neurological deficits)
• history of dementia and/or dementia range performance on the Mini- Mental State Examination (i.e., score of less than or equal to 23)
• prior diagnosis of Mild Cognitive Impairment (MCI) or Mild Neurocognitive Disorder unrelated to the participant's history of COVID-19
• history of severe psychiatric illness that may interfere with study participation or confound results (e.g., bipolar disorder, schizophrenia, or other psychotic disorder)
• history of significant neurodevelopmental condition that may interfere with study participation or confound results (e.g., intellectual disability, autism spectrum disorder, or specific learning disorder with impairment in reading)
• alcohol or other substance use disorder within the past 2 years
• significant sensory impairments (e.g., blindness) that would interfere with the ability to complete neuropsychological measures or engage in the tablet-based intervention
• performance that is below expectation on a test of effort and validity

Sponsors & Collaborators

• Cutter Lindbergh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

RECRUITING

MeSH Terms

Conditions

Inflammation; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Cutter Lindbergh, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Eddy, Ph.D., LMFT-S

CONTACT

860-679-3751; eddy@uchc.edu

Jennifer Brindisi, M.A.

CONTACT

860-679-7581; brindisi@uchc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a randomized two-arm, pre-post, clinical trial pilot study.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available no later than the end of the performance period with no end date.
• Access Criteria: It is planned to place anonymized data in a database called the National Archive of Computerized Data on Aging (NACDA). Access requires researchers to agree to refrain from sharing the data with others (no redistribution), not try to reidentify individuals, and to use the data only for research and statistical purposes. The information may be used for any type of research conducted in the future.

Locations

US (1)