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RECRUITING

NCT07171450

Cognitive Remediation

Sponsor: Cutter Lindbergh

View on ClinicalTrials.gov

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)

Official title: Computerized Cognitive Remediation of Postviral Neurocognitive Dysfunction in Older Adults

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-21

Completion Date

2030-02-28

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Aging Inflammation Cognitive Remediation Cognitive Dysfunction Postviral Syndrome Digital Medicine

Interventions

OTHER

Computerized Cognitive Remediation

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.

OTHER

Alternative Computer Activities

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.

Inclusion Criteria: * 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 * objective evidence of cognitive decline\*, as defined by performance on standardized measures of executive functioning, memory, or processing speed from the NIH Toolbox Cognition Battery that is at least 1 standard deviation below estimated premorbid cognitive functioning \[\*at least one third of the sample, or 25 out of 75 subjects, will be required to meet this inclusion criterion\] * fluent in English language * off psychiatric medication or on a stable dose for at least 8 weeks Exclusion Criteria: * 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

Locations (1)

UConn Health

Farmington, Connecticut, United States