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

May 30, 2023 updated by: Weill Medical College of Cornell University
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 85 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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).
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.
5 weeks (at the conclusion of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks
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).
Baseline, 5 weeks
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks
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.
Baseline, 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abhishek Jaywant, PhD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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