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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04098835
Enrollment
3
Registered
2019-09-23
Start date
2019-12-13
Completion date
2020-02-13
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

BEHAVIORALASCEND

ASCEND is a behavioral intervention that combines computer-based cognitive exercise, strategy coaching with a neuropsychologist, and homework exercises in order to improve attention, working memory, and cognitive control after stroke.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)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.
Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).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.

Secondary

MeasureTime frameDescription
Change in divided attention and working memory, as measured by the Symbol-Digit Modalities TestBaseline, 5 weeksPerformance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.
Change in divided attention and processing speed, as measured by the Trail Making TestBaseline, 5 weeksPerformance-based and timed measure of divided attention/processing speed with lower scores indicating better performance (faster completion time).
Change in selective attention and inhibitory control, as measured by the Stroop TestBaseline, 5 weeksPerformance-based and timed measure of selective attention and inhibition, with higher scores indicating better performance.
Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)Baseline, 5 weeksPerformance-based and timed measure of rapid working memory, with higher scores indicating better performance.
Change in auditory attention and working memory, as measured by the Digit Span testBaseline, 5 weeksPerformance-based measure of attention/working memory with scores ranging from 0-48, with higher scores indicating better performance.
Change in executive functioning as measured by the Weekly Calendar Planning ActivityBaseline, 5 weeksPerformance-based measure of executive functioning. Higher scores indicate better performance.
Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-AdultBaseline, 5 weeksSelf-report measure of executive functioning. Higher scores indicate greater problems with executive dysfunction in daily life.
Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).Baseline, 5 weeksSelf-report measure of cognitive difficulties after stroke. Scores range from 0-128 with higher scores indicating greater cognitive problems in daily life due to stroke.
Change in attention and working memory as measured by the Mental Control testBaseline, 5 weeksPerformance-based measure of simple auditory attention and working memory. Scores range from 0-12 with higher scores indicating better performance.
Change in visual attention and working memory, as measured by the Symbol Span testBaseline, 5 weeksPerformance-based measure of attention/working memory with scores ranging from 0-50, with higher scores indicating better performance.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026