Back to resultsA Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASCEND
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
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
Sites / Locations
- NewYork-Presbyterian Hospital/Weill Cornell Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASCEND
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
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.
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.
Change in executive functioning as measured by the Weekly Calendar Planning Activity
Performance-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-Adult
Self-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).
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.
Full Information
NCT ID
NCT04098835
First Posted
September 18, 2019
Last Updated
May 30, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04098835
Brief Title
A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
Official Title
A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
February 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASCEND
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ASCEND
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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.
Time Frame
5 weeks (at the conclusion of treatment)
Title
Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).
Description
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.
Time Frame
5 weeks (at the conclusion of treatment)
Secondary Outcome Measure Information:
Title
Change in auditory attention and working memory, as measured by the Digit Span test
Description
Performance-based measure of attention/working memory with scores ranging from 0-48, with higher scores indicating better performance.
Time Frame
Baseline, 5 weeks
Title
Change in visual attention and working memory, as measured by the Symbol Span test
Description
Performance-based measure of attention/working memory with scores ranging from 0-50, with higher scores indicating better performance.
Time Frame
Baseline, 5 weeks
Title
Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test
Description
Performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.
Time Frame
Baseline, 5 weeks
Title
Change in divided attention and processing speed, as measured by the Trail Making Test
Description
Performance-based and timed measure of divided attention/processing speed with lower scores indicating better performance (faster completion time).
Time Frame
Baseline, 5 weeks
Title
Change in selective attention and inhibitory control, as measured by the Stroop Test
Description
Performance-based and timed measure of selective attention and inhibition, with higher scores indicating better performance.
Time Frame
Baseline, 5 weeks
Title
Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)
Description
Performance-based and timed measure of rapid working memory, with higher scores indicating better performance.
Time Frame
Baseline, 5 weeks
Title
Change in attention and working memory as measured by the Mental Control test
Description
Performance-based measure of simple auditory attention and working memory. Scores range from 0-12 with higher scores indicating better performance.
Time Frame
Baseline, 5 weeks
Title
Change in executive functioning as measured by the Weekly Calendar Planning Activity
Description
Performance-based measure of executive functioning. Higher scores indicate better performance.
Time Frame
Baseline, 5 weeks
Title
Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult
Description
Self-report measure of executive functioning. Higher scores indicate greater problems with executive dysfunction in daily life.
Time Frame
Baseline, 5 weeks
Title
Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).
Description
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.
Time Frame
Baseline, 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Jaywant, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
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