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Clinical Trials/NCT04098835
NCT04098835
Terminated
Not Applicable

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

Weill Medical College of Cornell University1 site in 1 country3 target enrollmentDecember 13, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Weill Medical College of Cornell University
Enrollment
3
Locations
1
Primary Endpoint
Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 13, 2019
End Date
February 13, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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