RecruitingPhase 2NCT05507138

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke

Sponsor

Weill Medical College of Cornell University

Enrollment

70 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Depression Stroke Executive Dysfunction

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.

Eligibility

Min Age: 50 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study tests a digital (app-based) program designed to help stroke survivors who are experiencing depression and difficulty with planning, organizing, or problem-solving (called executive dysfunction). Participants will use the program remotely from home. **You may be eligible if...** - You had your first stroke at least 6 months ago - You have been diagnosed with depression following your stroke - You have difficulty with planning or organizing tasks (executive dysfunction, identified through screening tests) - You are able to use a digital device **You may NOT be eligible if...** - You have a history of stroke before your current one (this must be your first stroke) - You have a history of serious brain injury (TBI) - You have metal implants (shunts) in your brain - You have a history of significant heart disease, severe alcoholism, or drug use - You are unable to participate in computer-based tasks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAKL-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.

BEHAVIORALMetacognitive Strategy Training

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