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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04098835
Collaborator
(none)
20
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1
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ASCEND
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
Actual Study Start Date :
Dec 13, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. Change in auditory attention and working memory, as measured by the Digit Span test [Baseline, 5 weeks]

    Performance-based measure of attention/working memory with scores ranging from 0-48, with higher scores indicating better performance.

  2. Change in visual attention and working memory, as measured by the Symbol Span test [Baseline, 5 weeks]

    Performance-based measure of attention/working memory with scores ranging from 0-50, with higher scores indicating better performance.

  3. Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test [Baseline, 5 weeks]

    Performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.

  4. Change in divided attention and processing speed, as measured by the Trail Making Test [Baseline, 5 weeks]

    Performance-based and timed measure of divided attention/processing speed with lower scores indicating better performance (faster completion time).

  5. Change in selective attention and inhibitory control, as measured by the Stroop Test [Baseline, 5 weeks]

    Performance-based and timed measure of selective attention and inhibition, with higher scores indicating better performance.

  6. Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT) [Baseline, 5 weeks]

    Performance-based and timed measure of rapid working memory, with higher scores indicating better performance.

  7. Change in attention and working memory as measured by the Mental Control test [Baseline, 5 weeks]

    Performance-based measure of simple auditory attention and working memory. Scores range from 0-12 with higher scores indicating better performance.

  8. Change in executive functioning as measured by the Weekly Calendar Planning Activity [Baseline, 5 weeks]

    Performance-based measure of executive functioning. Higher scores indicate better performance.

  9. Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult [Baseline, 5 weeks]

    Self-report measure of executive functioning. Higher scores indicate greater problems with executive dysfunction in daily life.

  10. Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS). [Baseline, 5 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 89 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NewYork-Presbyterian Hospital/Weill Cornell Medical Center New York New York United States 10065

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT04098835
Other Study ID Numbers:
  • 19-06020310
First Posted:
Sep 23, 2019
Last Update Posted:
Dec 22, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2021