NCT05507138 · Weill Medical College of Cornell University
A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
What this study is about
Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the effectiveness of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies.
View original scientific description
Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.
Interventions
DEVICE
AKL-T01
AKL-T01 is an iPad-based video game designed to improve executive dysfunction and depression symptoms by targeting executive skills (multitasking) and ECN abnormalities.
BEHAVIORAL
Metacognitive Strategy Training
Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties
Primary outcome measures
Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)
Time frame: Baseline and end of treatment (6 weeks)
Change in score in the active intervention arm vs. the comparator arm on the SDMT, a performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- first-time stroke that occurred 6 months or more prior to study initiation
- executive dysfunction as defined by a score of less than 1 standard deviation below age-adjusted normative score on at least one test of executive function in the screening assessment
- diagnosis of Major Depressive Episode assessed by the Structured Clinical Interview for the DSM-5 (SCID).
- at least moderate depressive symptoms as defined by Montgomery Asberg Depression Rating Scale ≥ 18
- motor function sufficient to operate an iPad and use a pen, based on self-report and observation
- if treated with an antidepressant medication, must be on a stable dose for a minimum of 8 weeks at the time of study enrollment.
- able to adhere to all testing and study requirements and willingness to participate in the full study duration
Exclusion criteria
- receptive aphasia as determined by a score of 2 or 3 on the NIH Stroke Scale \[NIHSS\] item 9 ("Best Language")
- dysarthria that makes speech unintelligible (score of 2 on NIHSS item #10)
- severe visual impairment or hemispatial neglect (score of 3 on NIHSS item #3 or score of 2 on NIHSS item #11)
- patient already enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is already enrolled in psychotherapy, this will not be grounds for exclusion)
- non-fluency in English
- presence of or history of significant neurologic or neurodegenerative disorder other than stroke
- presence of dementia based on dependence in basic ADLs due to cognitive deficits
- history of psychosis or mania (evaluated using the SCID).
- active suicide ideation (assessed via the Columbia Suicide Severity Rating Scale)
- severe executive dysfunction (based on clinical judgment during screening evaluation) precluding use of the iPad
- severe depression-even in the absence of active suicidal ideation-based on the screening evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services.
- any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.
Where
- New York, New York
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations