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

NCT04098835 | Terminated

• 1 other identifier: 19-06020310
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change in auditory attention and working memory, as measured by the Digit Span test

  Baseline, 5 weeks

• Change in visual attention and working memory, as measured by the Symbol Span test

  Baseline, 5 weeks

• Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test

  Baseline, 5 weeks

• Change in divided attention and processing speed, as measured by the Trail Making Test

  Baseline, 5 weeks

• Change in selective attention and inhibitory control, as measured by the Stroop Test

  Baseline, 5 weeks

Study Arms (1)

ASCEND

EXPERIMENTAL

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

Interventions

ASCEND BEHAVIORAL

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.

ASCEND

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Abhishek Jaywant, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: December 13, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)