Actively Recruiting
Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
Led by Weill Medical College of Cornell University · Updated on 2026-04-22
70
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a digital treatment combining an iPad-based cognitive training program called AKL-T01 with metacognitive strategy coaching to improve executive dysfunction, depression symptoms, and daily function in individuals who have experienced a stroke. The study focuses on those with post-stroke depression and executive dysfunction, conditions linked to ongoing mood and cognitive challenges. Researchers will assess whether this combined treatment enhances brain connectivity and overall functioning compared to a control group. Participants in the intervention group will use the AKL-T01 program for 25 minutes a day, five days a week, over six weeks. This program involves multitasking exercises in a video game-like environment using an iPad. Alongside this, they will receive weekly 45-minute coaching sessions with a clinician to reflect on their experiences and develop strategies for daily activities. The control group will engage in general cognitive games on the iPad for the same duration and frequency, also paired with similar coaching sessions. Throughout the study, participants will undergo assessments at the start and end of the six-week treatment period. These include tests measuring executive function, depression symptoms, daily functioning, and brain connectivity through MRI scans. Researchers will monitor adherence to the treatment and evaluate changes using standardized tools such as the Oral Symbol Digit Modalities Test, Montgomery Asberg Depression Rating Scale, and resting state functional MRI. The total study duration for each participant is six weeks.
CONDITIONS
Brief Title
A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First-time stroke occurred 6 months or more before study start
- Executive dysfunction with score below 1 standard deviation on at least one executive function test
- Diagnosis of Major Depressive Episode by Structured Clinical Interview for DSM-5
- Montgomery Asberg Depression Rating Scale score of 18 or higher indicating moderate depression
- Sufficient motor skills to operate an iPad and use a pen
- Stable antidepressant medication dose for at least 8 weeks if applicable
- Ability and willingness to follow all study requirements and complete full study duration
You will not qualify if you...
- Receptive aphasia with severe language impairment based on NIH Stroke Scale
- Speech difficulty causing unintelligible speech
- Severe visual problems or hemispatial neglect
- Current participation in other cognitive rehabilitation
- Non-fluency in English
- History or presence of significant neurological or neurodegenerative disorder other than stroke
- Dementia causing dependence in basic daily activities
- History of psychosis or mania
- Active suicidal thoughts
- Severe executive dysfunction preventing iPad use
- Severe depression needing higher care or immediate psychiatric referral
- Pregnancy
- Any other clinical or medical reason making participation inappropriate as judged by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants complete daily digital interventions on an iPad along with weekly virtual coaching sessions to improve executive function and depression after stroke.
Daily sessions 5 days/week and weekly 45-minute virtual coaching sessions
Trial Site Locations
Total: 1 location
1
Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Alexandra Keenan, BS
A
Abhishek Jaywant, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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