Cognitive Remediation
ConditionsAgingInflammationCognitive RemediationCognitive DysfunctionPostviral SyndromeDigital 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Computerized Cognitive Remediation
Other interventionThe 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.
Alternative Computer Activities
Other interventionThe 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Computerized Cognitive RemediationExperimental treatment 1 intervention
Group B: Active Computer-Based ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-treatment and post-treatment (Week 7)2
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.
Time frame
Pre-treatment and 6 Months3
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.
Time frame
Post-Treatment (Week 7)Secondary outcomes
1
Group Difference in Inhibitory Control at Post-Treatment as Measured with the Stroop Color and Word Test
The Stroop Color and Word Test is an executive functioning measure of inhibitory control in which the examinee is presented with a sheet containing words of various colors printed in discordant ink colorings. The examinee is instructed to rapidly name the color of the ink that the words are printed in without reading the printed word (i.e., the prepotent response must be inhibited). An interference score is calculated by determining how many items the examinee completes within a set period of time, subtracting out their performance on baseline conditions (without an interference component) to control for processing speed. Higher scores indicate better performance. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Time frame
Pre-treatment and post-treatment (Week 7)2
Group Difference in Inhibitory Control at 6 Months as Measured with the Stroop Color and Word Test
The Stroop Color and Word Test is an executive functioning measure of inhibitory control in which the examinee is presented with a sheet containing words of various colors printed in discordant ink colorings. The examinee is instructed to rapidly name the color of the ink that the words are printed in without reading the printed word (i.e., the prepotent response must be inhibited). An interference score is calculated by determining how many items the examinee completes within a set period of time, subtracting out their performance on baseline conditions (without an interference component) to control for processing speed. Higher scores indicate better performance. The score at the 6-Month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Time frame
Pre-treatment and 6 months3
Group Difference in Verbal Generativity, Initiation, and Strategy Use at Post-Treatment as Measured with the Controlled Oral Word Association Test (COWAT)
The COWAT is an executive functioning measure of verbal generativity, initiation, and strategy use in which the examinee must quickly generate as many words as possible, within a set period of time, according to pre-specified rules (e.g., words starting with a certain letter of the alphabet). A total score is calculated by adding up the number of words that were correctly produced within the time limit. Higher total scores indicate better performance. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Time frame
Pre-treatment and post-treatment (Week 7)4
Group Difference in Verbal Generativity, Initiation, and Strategy Use at 6 Months as Measured with the Controlled Oral Word Association Test (COWAT)
The COWAT is an executive functioning measure of verbal generativity, initiation, and strategy use in which the examinee must quickly generate as many words as possible, within a set period of time, according to pre-specified rules (e.g., words starting with a certain letter of the alphabet). A total score is calculated by adding up the number of words that were correctly produced within the time limit. Higher total scores indicate better performance. The score at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Time frame
Pre-treatment and 6-monthsOther outcomes
1
Group Difference in Blood-Based Markers of Peripheral Inflammation at Post-Treatment
Following manufacturer guidelines, concentrations of inflammatory markers (IL-6, TNF-alpha, and CRP) in plasma will be quantified using commercially available assays. Plasma concentrations at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment concentrations.
Time frame
Pre-treatment and post-treatment (Week 7)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cutter Lindbergh
Lead sponsor
UConn Health
Sponsor institution
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov