Executive DysfunctionPhase 2NCT05507138
A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
A Phase 2 study testing AKL-T01 and Metacognitive Strategy Training in people with Executive Dysfunction and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Executive Dysfunction, Depression, Stroke
- What is being tested?
- AKL-T01 and Metacognitive Strategy Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical Center
New York, New York, 10065
Abhishek Jaywant, PhD, 646-289-5204 ext. 717, abj2006@med.cornell.edu
About this study
Official title: Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
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.
Read the detailed description
Post-stroke depression with executive dysfunction (DED) is associated with persistent mood and cognitive disturbance, poor social functioning, and disability. Existing interventions have limited evidence of efficacy, side effects, and can be difficult for stroke patients to access. This study aims to evaluate a remote digital intervention for post-stroke DED that combines iPad-based cognitive training using a program called AKL-T01 with virtual coaching to improve executive dysfunction, depression, and daily function after stroke. The primary hypothesis is that individuals randomized to the intervention arm (AKL-T01 + coaching) will demonstrate greater improvement in their executive functioning and depression symptoms and daily function relative to the comparator arm. The secondary hypothesis is that individuals randomized to the intervention arm will demonstrate greater increase in the functional connectivity of the executive control network (ECN, assessed with an MRI scan) at the conclusion of treatment, relative to participants randomized to the comparator arm.
- Conditions
- Executive Dysfunction, Depression, Stroke
- Being tested
- AKL-T01, Metacognitive Strategy Training
- Medical subject headings
- Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKL-T01Device
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 TrainingBehavioural
Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties
| Study group | Role | What they receive |
|---|---|---|
| AKL-T01 | Experimental | 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. Receives: Device: AKL-T01; Behavioral: Metacognitive Strategy Training |
| Enhanced Metacognitive Strategy Training | Placebo comparator | 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. Receives: Behavioral: Metacognitive Strategy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)
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.
Measured: Baseline and end of treatment (6 weeks)
Secondary outcomes (7)
Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Change in score in the active intervention arm vs. the comparator arm on the MADRS, a clinician-rated assessment of depression symptom severity that consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depression symptom severity.
Measured: Baseline and end of treatment (6 weeks)
Change in depression symptoms, as measured by the 9-item Patient Health Questionnaire (PHQ-9)
Change in score in the active intervention arm vs. the comparator arm on the PHQ-9, a self-report questionnaire of depression symptom frequency. Scores range from 0-27, where higher scores are indicative of greater depression symptoms.
Measured: Baseline and end of treatment (6 weeks)
Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form
Change in score in the active intervention arm vs. the comparator arm on the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form, a self-report questionnaire of a person's perceived difficulties in cognitive abilities or in their application of such abilities to everyday tasks. Scores range from 8-40 with lower scores representing greater cognitive difficulties.
Measured: Baseline and end of treatment (6 weeks)
Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA)
Change in score in the active intervention arm vs. the comparator arm on the WCPA, a performance based assessment that involves following and organizing a list of appointments or errands into a weekly schedule. Scoring is from 0-17 points, with higher scores indicating better performance.
Measured: Baseline and end of treatment (6 weeks)
Change in connectivity in the executive control network, as assessed by resting state functional MRI (rs-fMRI).
Change in functional connectivity in the active intervention arm vs. the comparator arm assessed by an rs-fMRI scan.
Measured: Baseline and end of treatment (6 weeks)
Change in executive function, as measured by the NIH Toolbox Flanker test
Change in total score in the active intervention arm vs. the comparator arm on the NIH Toolbox Flanker test, a timed iPad-based test of executive function where participants have to respond to certain stimuli while ignoring distractors. Score ranges between 0-10, with a higher score indicating better performance.
Measured: Baseline and end of treatment (6 weeks)
Change in executive function, as measured by the Frontal Systems Behavior Rating Scale (FrSBe)
Change in score in the active intervention arm vs. the comparator arm on the FrSBE, a brief behavioral rating scale for the assessment of behavior disturbances associated with damage to the frontal-subcortical brain circuits. The FrSBe is a 46-item rating scale with three subscales: Apathy, Disinhibition, and Executive Dysfunction. Raw scores range from 46 to 230 overall, which are converted to age adjusted T scores for the Apathy, Disinhibition, and Executive Dysfunction subscales. T scores < 50 reflect less symptoms of apathy, disinhibition, and executive dysfunction. T scores > 50 reflect greater symptoms of apathy, disinhibition, and executive dysfunction.
Measured: Baseline and end of treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Mar 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to the AKL-T01 intervention plus weekly metacognitive strategy coaching (intervention arm) or to weekly metacognitive strategy coaching plus general cognitive stimulation games such as word searches and other puzzles (control arm).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Abhishek Jaywant, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507138
- Sponsor's protocol ID
- 21-11024159
- Other IDs
- 1K23MH129849-01A1
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: At the conclusion of the study, and after we publish our main results, a deidentified database of individual participant will be available for data sharing. Additionally, we will share study protocol, statistical analysis plan, and analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
- ClinicalTrials.gov ID
- NCT05507138
- Acronym / sponsor ID
- 21-11024159
- Conditions
- Executive Dysfunction, Depression, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-stroke depression with executive dysfunction (DED) is associated with persistent mood and cognitive disturbance, poor social functioning, and disability. Existing interventions have limited evidence of efficacy, side effects, and can be difficult for stroke patients to access. This study aims to evaluate a remote digital intervention for post-stroke DED that combines iPad-based cognitive training using a program called AKL-T01 with virtual coaching to improve executive dysfunction, depression, and daily function after stroke. The primary hypothesis is that individuals randomized to the intervention arm (AKL-T01 + coaching) will demonstrate greater improvement in their executive functioning and depression symptoms and daily function relative to the comparator arm. The secondary hypothesis is that individuals randomized to the intervention arm will demonstrate greater increase in the functional connectivity of the executive control network (ECN, assessed with an MRI scan) at the conclusion of treatment, relative to participants randomized to the comparator arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to the AKL-T01 intervention plus weekly metacognitive strategy coaching (intervention arm) or to weekly metacognitive strategy coaching plus general cognitive stimulation games such as word searches and other puzzles (control arm).
| Arm | Type | Receives |
|---|---|---|
| AKL-T01 | Experimental | Device: AKL-T01, Behavioral: Metacognitive Strategy TrainingParticipants 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. |
| Enhanced Metacognitive Strategy Training | Placebo comparator | Behavioral: Metacognitive Strategy TrainingIn 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. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKL-T01AKL-T01 is an iPad-based video game designed to improve executive dysfunction and depression symptoms by targeting executive skills (multitasking) and ECN abnormalities. | Device | AKL-T01 |
| Metacognitive Strategy TrainingMetacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties | Behavioural | AKL-T01, Enhanced Metacognitive Strategy Training |
Primary outcome
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.
7 secondary outcomes
Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and end of treatment (6 weeks)
Change in depression symptoms, as measured by the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and end of treatment (6 weeks)
Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form
Time frame: Baseline and end of treatment (6 weeks)
Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA)
Time frame: Baseline and end of treatment (6 weeks)
Change in connectivity in the executive control network, as assessed by resting state functional MRI (rs-fMRI).
Time frame: Baseline and end of treatment (6 weeks)
Change in executive function, as measured by the NIH Toolbox Flanker test
Time frame: Baseline and end of treatment (6 weeks)
Change in executive function, as measured by the Frontal Systems Behavior Rating Scale (FrSBe)
Time frame: Baseline and end of treatment (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. At the conclusion of the study, and after we publish our main results, a deidentified database of individual participant will be available for data sharing. Additionally, we will share study protocol, statistical analysis plan, and analytic code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhishek Jaywant, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AKL-T01 and Metacognitive Strategy Training in people with Executive Dysfunction and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Keenan, BS (212-746-1509, alk4028@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.