Cognitive Training in Stroke Rehabilitation

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Cognitive Impairment; Executive Dysfunction

Treatments: Behavioral: ASCEND-I

Study type: Interventional

Funder types: Other

Identifiers

NCT04472351

20-05022146

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 30 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

ASCEND-I

Experimental group

Description:

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.

Treatment:

Behavioral: ASCEND-I

Enhanced Usual Care

No Intervention group

Description:

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.