Cognitive Remediation

ConditionsAging Inflammation Cognitive Remediation Cognitive Dysfunction Postviral Syndrome Digital Medicine

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorCutter Lindbergh

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

Computerized Cognitive Remediation
Alternative Computer Activities

Treatment groups

75 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Cutter Lindbergh

Lead sponsor

UConn Health

Sponsor institution

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov