Clinical trial NCT04472351: Cognitive Training in Stroke Rehabilitation
Official title: Strategy Training for Cognitive Dysfunction in Inpatient Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Executive Dysfunction
Cognitive Impairment
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: Baseline, end of study (approximately 2 weeks)
Secondary outcomes:
measure: Change from baseline in working memory function, as measured by additional tasks on TabCAT.
timeFrame: Baseline, end of study (approximately 2 weeks)
measure: Change from baseline in cognitive functioning, as measured by the NeuroQOL (Quality of Life in Neurological disorders) Cognitive Function Short Form.
timeFrame: Baseline, end of study (approximately 2 weeks)
measure: Change from baseline in strategy use, as measured by the Weekly Calendar Planning Activity (WCPA)
timeFrame: Baseline, end of study (approximately 2 weeks)
measure: Mood symptoms-assessment using the PHQ9 and GAD7-will also be used as exploratory variables in outcome analyses.
timeFrame: Baseline, end of study (approximately 2 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Abhishek Jaywant, PhD
role: PRINCIPAL_INVESTIGATOR
References: