Cognitive Training in Stroke Rehabilitation

Cognitive Impairment Clinical Trial

Official title:

Strategy Training for Cognitive Dysfunction in Inpatient Stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472351
• Other study ID #: 20-05022146
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Weill Medical College of Cornell University
• Contact: Abhishek Jaywant, PhD
• Phone: 212-746-1500
• Email: abj2006[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled pilot study to evaluate the efficacy of "ASCEND-I" (A Strategy and Computer-based intervention to ENhance Daily cognitive functioning after stroke - Inpatient), an inpatient intervention that combines computer-based cognitive training and coaching of cognitive strategies to improve working memory (WM) and related executive functions in individuals with stroke. The investigators hypothesize that relative to an "enhanced usual care" control condition, ASCEND will be associated with improvements in WM. The investigators also hypothesize that measures of baseline brain connectivity (assessed via participants' routine clinical magnetic resonance imaging scans) will predict response to ASCEND-I.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Patient admitted for a stroke and accepted to acute inpatient rehabilitation at NYP-Weill Cornell.

2. Age 30-89

3. English speaking

4. Ability to comprehend sufficiently to participate in the treatment

5. Mild-moderate cognitive impairment as determined by a standard of care cognitive screening tools administered by occupational therapists (e.g., Montreal Cognitive Assessment, Symbol-Digit Modalities Test, or other clinical standard of care instrument). We will review subjects' most recent cognitive assessment administered by OT (Occupational Therapists) and available in the EMR (Electronic Medical Records) to determine eligibility.

6. Willingness to participate in full study duration

7. Physically able to operate a computer keyboard, tablet/iPad, and mouse.

Exclusion Criteria:

1. History of other neurologic disorder (e.g., Parkinson's disease, Multiple Sclerosis, Alzheimer's disease, brain tumor). History of previous stroke(s) will not be exclusionary as long as the subject does not self-report having lasting/persistent cognitive impairment from the prior stroke.

2. History of severe mental illness (e.g., schizophrenia, psychosis) or substance use disorder, recent history (in the past year) of alcohol/substance use disorder or symptoms of psychosis. Note that the presence of post-stroke depression will not be grounds for exclusion.

3. History of dementia

4. Moderate-severe hemispatial neglect as determined by OT evaluation

5. Any factor that in the investigator's opinion is likely to compromise the subject's ability to participate in the study, including evidence that the subject may not understand and/or adhere to study requirements

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Executive Dysfunction

Intervention

Behavioral:
• ASCEND-I
The intervention is an inpatient version of a novel behavioral intervention named "ASCEND" (A Strategy and Computer-based Intervention to ENhance Daily Cognitive Functioning after Stroke). ASCEND-I combines computer-based cognitive training exercises, with structured coaching sessions within patients' occupational therapy. Computer-based training is 30 minutes in length daily, and strategy training within patients' occupational therapy ranges from 30-60 minutes (depending on patients' clinical goals). The computer exercises aim to improve working memory (WM) through a series of engaging and interactive computer games (e.g., card games, virtual shopping, mental arithmetic). The Multicontext OT sessions aim to assist the participant in generalizing and transferring skills from the computer exercises to everyday activities and to develop further strategies to compensate for WM difficulties.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to determine whether ASCEND improves WM as assessed by computerized WM tasks from the Tablet-based Computer Assessment Tool (TabCAT) and the Weekly Calendar Planning Activity.	TabCAT is a computer-based assessment tool which includes a series of tests to determine memory and executive functioning. The subtest TabCAT Match will be used to determine the the primary outcome. It is a standardized and validated measure of WM, and requires participants to hold in mind symbol-number pairings in working memory and respond to probe stimuli on the screen based on these pairings.; The WCPA is a standardized, performance-based, ecologically-valid measure of executive functioning in which the participant has to organize a list of appointments into a weekly schedule. The outcome variable is the percentage of appointments entered correctly relative to the total number of appointments entered.	Baseline, end of study (approximately 2 weeks)
Secondary	Change from baseline in working memory function, as measured by additional tasks on TabCAT.	The secondary outcomes are performance on additional tasks of WM and related cognitive functions on the TabCAT platform, which are working memory, inhibitory control, cognitive flexibility, and learning/memory. The TabCAT subtests utilized to measure the above are Favorites, Set Shifting, Running Dots, Dot Counting, and Flanker. High scores on these tasks would mean that the participant is using the WM strategies that they learnt during the treatment session.	Baseline, end of study (approximately 2 weeks)
Secondary	Change from baseline in cognitive functioning, as measured by the NeuroQOL (Quality of Life in Neurological disorders) Cognitive Function Short Form.	NeuroQOL is a self-report questionnaires used to determine cognitive difficulties in participants' tasks of daily living. Scores range from 8-40 where lower score indicate that the participant experiences cognitive difficulties in their daily tasks and higher scores indicate minimum or no cognitive difficulties.	Baseline, end of study (approximately 2 weeks)
Secondary	Change from baseline in strategy use, as measured by the Weekly Calendar Planning Activity (WCPA)	The WCPA is a standardized, performance-based, ecologically-valid measure of executive functioning in which the participant has to organize a list of appointments into a weekly schedule. The outcome variable is the total number of strategies used in the WCPA.	Baseline, end of study (approximately 2 weeks)
Secondary	Mood symptoms-assessment using the PHQ9 and GAD7-will also be used as exploratory variables in outcome analyses.	The PHQ9 and GAD7 are standardized tests to determine the anxiety and depression levels of the participants.	Baseline, end of study (approximately 2 weeks)