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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Behavioral: ASCEND

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abhishek Jaywant, PhD; Phone Number: 212-746-4666; Email: abj2006@med.cornell.edu
• Study Contact Backup: Name: Alexandra Keenan, BA; Phone Number: 212-746-1509; Email: alk4028@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • NewYork-Presbyterian Hospital/Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ASCEND; ASCEND combines computer-based cognitive training exercises, homework exercises to enhance cognition, and coaching sessions delivered in-person and via telephone/videoconference by a neuropsychologist. ASCEND includes 24 total computer training sessions of 30 minutes each, for a total of 12 hours. ASCEND includes 8 coaching sessions of 45 minutes each. The computer exercises aim to improve attention, working memory (WM), and cognitive control through a series of engaging and interactive computer games (e.g., card games, driving simulation). The homework exercises and coaching sessions aim to assist the participant in generalizing and transferring skills from the computer exercises to daily life and to develop further strategies to compensate for attention and WM difficulties in daily life.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Abhishek Jaywant, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): February 13, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 19-06020310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No