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临床试验/NCT04098835
NCT04098835终止不适用

A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).

研究概览

简要总结

This is an initial pilot study to test feasibility, participant engagement and satisfaction, and clinical and neurobiological target engagement of a behavioral treatment called "ASCEND" that combines computer-based cognitive training and coaching of cognitive strategies to improve daily cognitive functioning in individuals with stroke.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of first-time stroke, minimum of 6 months prior to enrollment
  • English speaking
  • Ability to comprehend sufficiently to participate in the treatment.
  • Subjective or objective evidence of mild cognitive impairment
  • Willingness to participate in full study duration
  • Has computer that meets specification for the training program software.
  • Physically able to operate a computer keyboard and mouse.
  • Not concurrently receiving other cognitive rehabilitation services
  • Cognitively able to perform basic self-care activities (e.g., dressing, grooming, eating).

排除标准

  • History of neurologic disease other than stroke
  • History of severe mental illness or substance use disorder, or current major depressive episode.
  • History of dementia or dependence in basic self-care activities due to cognitive deficits
  • Contraindications to MRI

结局指标

主要结局

Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).

时间窗: 5 weeks (at the conclusion of treatment)

The CEQ is a self-report measure that assesses participants' perceived benefit and improvement from the intervention. Each item is scored on a 1-9 Likert-type scale or as a percentage rating from 0% to 100% in 10% increments.

Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)

时间窗: 5 weeks (at the conclusion of treatment)

The CSQ-8 is a self-report measure of participant satisfaction with the intervention. Scores range from 8-32 with higher scores indicating greater satisfaction.

次要结局

  • Change in attention and working memory as measured by the Mental Control test(Baseline, 5 weeks)
  • Change in visual attention and working memory, as measured by the Symbol Span test(Baseline, 5 weeks)
  • Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test(Baseline, 5 weeks)
  • Change in divided attention and processing speed, as measured by the Trail Making Test(Baseline, 5 weeks)
  • Change in selective attention and inhibitory control, as measured by the Stroop Test(Baseline, 5 weeks)
  • Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)(Baseline, 5 weeks)
  • Change in auditory attention and working memory, as measured by the Digit Span test(Baseline, 5 weeks)
  • Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).(Baseline, 5 weeks)
  • Change in executive functioning as measured by the Weekly Calendar Planning Activity(Baseline, 5 weeks)
  • Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult(Baseline, 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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