Cognitive Remediation

Официальное название

Computerized Cognitive Remediation of Postviral Neurocognitive Dysfunction in Older Adults

Обзор

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)

Подробное описание

A significant minority of older adults display persistent cognitive impairments after the acute phase of a viral infection, referred to as Postviral Neurocognitive Dysfunction (PND). Underlying mechanisms remain poorly understood, though chronic neuroinflammation appears to reflect a key pathway. PND is debilitating, increases the risk for accelerated biological aging and dementia, and is associated with a substantial economic burden to society. Older adults are at heightened risk for PND given weakened immune systems, baseline age-related cognitive decline, and susceptibility to more severe acute viral illness. There is a critical lack of evidence-based treatments. The goal of this project is to determine the potential of a neuroplasticity-based computerized cognitive remediation (CCR) intervention for treating PND in older adults and probing underlying mechanisms.

The proposed design is a randomized, two-arm, clinical trial pilot study. Older adults with PND (N = 75) will be assigned to a 6-week course of neuroplasticity-based CCR or an active, computer-based control condition. Specific aims are to: examine preliminary efficacy of CCR for improving cognitive performance and day-to-day functioning in older adults with PND (Aim 1); optimize and refine the CCR program for older adults with PND using iterative, data-driven, participatory design methodology (Aim 2); and determine if CCR reduces peripheral inflammation as a potential mechanism of clinical symptom relief (Exploratory Aim 3).

Вмешательства

• Другое 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 i
• Другое 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.

Первичные конечные точки

• Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B [Срок оценки: Pre-treatment and post-treatment (Week 7)]
• Group Difference in Set-Shifting Abilities at 6 Months as Measured with Trails B [Срок оценки: Pre-treatment and 6 Months]
• User Experience/Interface with Computerized Cognitive Remediation Program at Post-Treatment as Measured with the System Usability Scale [Срок оценки: Post-Treatment (Week 7)]

Вторичные конечные точки (12)

• Group Difference in Inhibitory Control at Post-Treatment as Measured with the Stroop Color and Word Test [Срок оценки: Pre-treatment and post-treatment (Week 7)]
• Group Difference in Inhibitory Control at 6 Months as Measured with the Stroop Color and Word Test [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Pre-treatment and 6-months]
• Group Difference in Attention-Related Problems at Post-Treatment as Measured with the Conners Continuous Performance Test [Срок оценки: Pre-treatment and post-treatment (Week 7)]
• Group Difference in Attention-Related Problems at 6 Months as Measured with the Conners Continuous Performance Test [Срок оценки: Pre-treatment and 6-months]
• Group Difference in Subjective Cognitive Concerns at Post-Treatment as Measured with the Everyday Cognition Scale (ECog) [Срок оценки: Pre-treatment and post-treatment (Week 7)]
• Group Difference in Subjective Cognitive Concerns at 6 Months as Measured with the Everyday Cognition Scale (ECog) [Срок оценки: Pre-treatment and 6-months]
• Group Difference in Functional Disability at Post-Treatment as Measured with the World Health Organization Disability Assessment Schedule (WHODAS) [Срок оценки: Pre-treatment and post-treatment (Week 7)]
• Group Difference in Functional Disability at 6 Months as Measured with the World Health Organization Disability Assessment Schedule (WHODAS) [Срок оценки: Pre-treatment and 6-months]
• Group Difference in Episodic Memory at Post-Treatment as Measured with the California Verbal Learning Test (CVLT) [Срок оценки: Pre-treatment and post-treatment (Week 7)]
• Group Difference in Episodic Memory at 6 Months as Measured with the California Verbal Learning Test (CVLT) [Срок оценки: Pre-treatment and 6-months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UConn Health — Farmington

Идентификаторы

NCT: NCT07171450 · 25-389-2 · 1K23AG086612-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗