Clinical trial NCT04098835: A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
Official title: A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 3
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 5 weeks (at the conclusion of treatment)
measure: Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).
timeFrame: 5 weeks (at the conclusion of treatment)
Secondary outcomes:
measure: Change in auditory attention and working memory, as measured by the Digit Span test
timeFrame: Baseline, 5 weeks
measure: Change in visual attention and working memory, as measured by the Symbol Span test
timeFrame: Baseline, 5 weeks
measure: Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test
timeFrame: Baseline, 5 weeks
measure: Change in divided attention and processing speed, as measured by the Trail Making Test
timeFrame: Baseline, 5 weeks
measure: Change in selective attention and inhibitory control, as measured by the Stroop Test
timeFrame: Baseline, 5 weeks
measure: Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline, 5 weeks
measure: Change in attention and working memory as measured by the Mental Control test
timeFrame: Baseline, 5 weeks
measure: Change in executive functioning as measured by the Weekly Calendar Planning Activity
timeFrame: Baseline, 5 weeks
measure: Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult
timeFrame: Baseline, 5 weeks
measure: Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).
timeFrame: Baseline, 5 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Abhishek Jaywant, PhD
role: PRINCIPAL_INVESTIGATOR
References: