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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04098835
• Other study ID #: 19-06020310
• Status: Terminated
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: May 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• ASCEND
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.

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)	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.	5 weeks (at the conclusion of treatment)
Primary	Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).	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.	5 weeks (at the conclusion of treatment)
Secondary	Change in auditory attention and working memory, as measured by the Digit Span test	Performance-based measure of attention/working memory with scores ranging from 0-48, with higher scores indicating better performance.	Baseline, 5 weeks
Secondary	Change in visual attention and working memory, as measured by the Symbol Span test	Performance-based measure of attention/working memory with scores ranging from 0-50, with higher scores indicating better performance.	Baseline, 5 weeks
Secondary	Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test	Performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.	Baseline, 5 weeks
Secondary	Change in divided attention and processing speed, as measured by the Trail Making Test	Performance-based and timed measure of divided attention/processing speed with lower scores indicating better performance (faster completion time).	Baseline, 5 weeks
Secondary	Change in selective attention and inhibitory control, as measured by the Stroop Test	Performance-based and timed measure of selective attention and inhibition, with higher scores indicating better performance.	Baseline, 5 weeks
Secondary	Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)	Performance-based and timed measure of rapid working memory, with higher scores indicating better performance.	Baseline, 5 weeks
Secondary	Change in attention and working memory as measured by the Mental Control test	Performance-based measure of simple auditory attention and working memory. Scores range from 0-12 with higher scores indicating better performance.	Baseline, 5 weeks
Secondary	Change in executive functioning as measured by the Weekly Calendar Planning Activity	Performance-based measure of executive functioning. Higher scores indicate better performance.	Baseline, 5 weeks
Secondary	Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult	Self-report measure of executive functioning. Higher scores indicate greater problems with executive dysfunction in daily life.	Baseline, 5 weeks
Secondary	Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).	Self-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.	Baseline, 5 weeks