Assessing the Effectiveness of Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Acceptability Scale
研究概览
简要总结
This pilot randomized controlled trial is to investigate the feasibility and efficacy of cognitive rehabilitation for patients with post-COVID-19 cognitive impairment. Additionally, the study will obtain preliminary data, using rsfMRI, regarding the potential underlying connectivity networks, mediating the effect of CR on cognitive improvements.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age
- •Have a confirmed SARS-CoV-2 infection (positive PCR or are serum antibody positive [against spike protein if unvaccinated or N-capsid peptide if vaccinated])
- •Speak English
- •Have objective mild to moderate cognitive impairment, which will be defined as impairment in executive function (a z-score >1.5 standard deviations below the normative mean) and in at least one other cognitive domain
- •Endorse comfort and familiarity with technology.
排除标准
- •No method of contact
- •Major neurocognitive disorder, as defined by a score <17 on the Montreal Cognitive Assessment (MoCA)
- •History of pre-COVID-19 neurologic disease (e.g., stroke)
- •History of severe head injury (as defined by loss of consciousness >30 minutes)
- •Ongoing substance use disorder (Mini International Neuropsychiatric Interview Version 7.0.2 [MINI] or Alcohol Use Disorders Test-Consumption [AUDIT-C] >8)
- •Unstable medical, neurologic, or psychiatric conditions precluding participation in research activities, and
- •Contraindication for MRI (e.g., metallic/electronic implants).
- •Not involved in cognitive rehabilitation/training or daily meditative practices during study enrollment
结局指标
主要结局
Acceptability Scale
时间窗: end of study, at 12 months
Acceptability: using 7 Likert-rated items (scores will be coded as: Low: ≤3; Moderate: 3-3.9; Good: ≥4). Full range from 1-7, with higher score indicating higher acceptability.
Treatment Credibility and Expectancy Questionnaire.
时间窗: end of study, at 12 months
Participants' beliefs about how likely they are to benefit from the intervention using the Treatment Credibility and Expectancy Questionnaire. Full scale from 0-10, with higher score indicating higher treatment expectancy.
Resting state functional connectivity (rsFC)
时间窗: end of study, at 12 months
Neuroimaging Outcomes: Resting state functional connectivity (rsFC) within the central executive network (CEN).
Trail Making Test - Part B
时间窗: end of study, at 12 months
Trail Making Test - Part B: a measure of aspects of executive functioning (e.g., set- shifting and cognitive flexibility), where participants connect the dots on a page scattered with numbers and letters in alternating sequence. Scored by time in seconds. Higher number of seconds implies deficiencies in cognitive functioning.
Enrollment yield
时间窗: end of study, at 12 months
Practicality measured by enrollment yield which is #enrolled/approached.
Wisconsin Card Sorting Task (WCST)-64
时间窗: end of study, at 12 months
Wisconsin Card Sorting Task (WCST)-64: Computer Version 2. The WCST-64 is a measure of executive functioning assessing novel problem solving and abstract thinking. The software scores the test and generates percentile scores (0-100). Scored by percentile. Higher percentile implies scoring better than others who have completed the task.
Dropout number
时间窗: end of study, at 12 months
Practicality measured by number of dropout
Staff Practicality
时间窗: end of study, at 12 months
Open-ended questions to staff regarding challenges conducting intervention (e.g., difficulty enrolling, reaching, engaging participants; scores will be coded as: Low: \<50%; Moderate: 50-70%; Good: \>70%).
次要结局
- The Hopkins Verbal Learning Test-Revised (HVLT-R)(end of study, at 12 months)
- Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4)(end of study, at 12 months)
- Trail Making Test, Part A(end of study, at 12 months)
- The Symbol Digit Modalities Text (SDMT)(end of study, at 12 months)
- NACC battery's verbal phonemic and category fluency tests(end of study, at 12 months)
- NACC battery's abbreviated Multilingual Naming Test (MINT)(end of study, at 12 months)
- National Alzheimer's Coordinating Center (NACC) battery's Number Span(end of study, at 12 months)
- Paced Auditory Serial Addition Task (PASAT)(end of study, at 12 months)
研究者
Juan Wisnivesky
Chief, Division of General Internal Medicine
Icahn School of Medicine at Mount Sinai