A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Stroke Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Executive Dysfunction
• Stroke

• NCT number: NCT05507138
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Contact: Alexandra Keenan, BS
• Phone: 212-746-1509
• Email: alk4028@med.cornell.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Completion date: July 1, 2026