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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098835
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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
Stroke Behavioral: ASCEND Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 13, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

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.




Primary Outcome Measures :
  1. Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: 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). [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098835


Contacts
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Contact: Abhishek Jaywant, PhD 212-746-4666 abj2006@med.cornell.edu
Contact: Ryan Lowder, BA 212-746-1509 ryl2004@med.cornell.edu

Locations
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United States, New York
NewYork-Presbyterian Hospital/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Abhishek Jaywant, PhD    212-746-4666    abj2006@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Abhishek Jaywant, PhD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04098835    
Other Study ID Numbers: 19-06020310
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases