Recruiting
Phase 2

Digital Intervention

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05507138

Conditions

Executive Dysfunction

Depression

Stroke

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

AKL-T01

Metacognitive Strategy Training

Study Details

Brief summary:

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.

Conditions

Executive Dysfunction

Depression

Stroke

Study ID

NCT05507138

Start date

Mar 1, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.
  • pregnancy
  • any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AKL-T01

Participants in the intervention group will complete 25 minutes of AKL-T01 per day, 5 days/week, for 6 weeks. AKL-T01 trains rapid multitasking on an iPad in an immersive videogame-like environment. Participants complete go/no-go + navigation exercises by moving the iPad to navigate a character on a path while tapping when a certain stimulus is presented and ignoring other stimuli. Participants will also receive weekly 45-minute metacognitive strategy coaching sessions delivered by a clinician. Sessions use guided questions and worksheets (shared virtually) to help participants reflect on their experience with AKL-T01 and link it to daily functioning, generate strategies for daily activities, and explore any emotional responses that arise during gameplay.

placebo comparator: Enhanced Metacognitive Strategy Training

In the control group, participants will complete-at the same frequency and duration as the intervention group-iPad-based games designed to provide general cognitive stimulation (word searches, checkers, and "spot the differences" between two pictures). Concurrently with these cognitive stimulation games, participants will receive weekly metacognitive strategy coaching sessions akin to that described above.

Interventions

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.

Metacognitive Strategy Training

Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties

Primary outcome measure

  • Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline and end of treatment (6 weeks) ]

Central Contacts and Locations

Central contacts

Alexandra Keenan, BS

212-746-1509alk4028@med.cornell.edu

Abhishek Jaywant, PhD

646-289-5204abj2006@med.cornell.edu

Locations

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Abhishek Jaywant, PhD

646-289-5204abj2006@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.