Computerized Cognitive Remediation of Postviral Neurocognitive Dysfunction in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B
研究概览
简要总结
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)
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Computer-Based Control
干预措施: Alternative Computer Activities (Other)
Computerized Cognitive Remediation
干预措施: Computerized Cognitive Remediation (Other)
结局指标
主要结局
Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B
时间窗: Pre-treatment and post-treatment (Week 7)
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.
Group Difference in Set-Shifting Abilities at 6 Months as Measured with Trails B
时间窗: Pre-treatment and 6 Months
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.
User Experience/Interface with Computerized Cognitive Remediation Program at Post-Treatment as Measured with the System Usability Scale
时间窗: Post-Treatment (Week 7)
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.
次要结局
- 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))
- Group Difference in Attention-Related Problems at 6 Months as Measured with the Conners Continuous Performance Test(Pre-treatment and 6-months)
- Group Difference in Subjective Cognitive Concerns at Post-Treatment as Measured with the Everyday Cognition Scale (ECog)(Pre-treatment and post-treatment (Week 7))
- Group Difference in Subjective Cognitive Concerns at 6 Months as Measured with the Everyday Cognition Scale (ECog)(Pre-treatment and 6-months)
- Group Difference in Functional Disability at Post-Treatment as Measured with the World Health Organization Disability Assessment Schedule (WHODAS)(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)(Pre-treatment and 6-months)
- Group Difference in Episodic Memory at Post-Treatment as Measured with the California Verbal Learning Test (CVLT)(Pre-treatment and post-treatment (Week 7))
- Group Difference in Episodic Memory at 6 Months as Measured with the California Verbal Learning Test (CVLT)(Pre-treatment and 6-months)
研究者
Cutter Lindbergh
Assistant Professor
UConn Health