Cognitive Training in Stroke Rehabilitation

NCT ID: NCT04472351

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-09-15

Brief 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.

Conditions

Executive Dysfunction; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ASCEND-I

Computerized WM training with Rehacom will be implemented in daily 30-minute sessions that are scheduled prior to the participant's occupational therapy (OT) session as an adjunct to routine rehabilitation. Tasks are tailored to the participant's current ability level and are adaptive to performance changes. During these sessions, the study staff member will use guided questioning to help the participant anticipate challenges, reflect on performance, and link computerized exercises to the Multicontext sessions. The Multicontext treatment sessions will be delivered within the participant's OT session by an OT. The Multicontext approach helps individuals to self-discover WM-related error patterns and learn to anticipate WM performance challenges through repeated practice using functionally-relevant activities. The OT conducts guided questioning pre- and post-task to help the participant anticipate challenges and self-discover WM strategies.

Group Type: EXPERIMENTAL

ASCEND-I

Intervention Type: BEHAVIORAL

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.

Enhanced Usual Care

The control condition will account for the time spent with rehabilitation therapists and study staff and provide more general cognitive stimulation. The control group will receive usual, standard of care occupational therapy during OT by inpatient rehabilitation staff who are not trained in the Multicontext approach. The standard OT session often focuses on cognition in a non-standardized and non-targeted manner without the targeting of WM and guided self-discovery of the Multicontext approach. To control for the cognitive training element of ASCEND, individuals randomized to the control condition will meet with a study staff member for 30 minutes of general cognitive stimulation that includes word-searches, crossword puzzles, and/or jigsaw puzzles.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abhishek Jaywant, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

20-05022146

Identifier Type: -

Identifier Source: org_study_id