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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Weill Cornell Medical Center
RECRUITING
New York
Contact Information
Primary
Alexandra Keenan, BS
alk4028@med.cornell.edu
212-746-1509
Backup
Abhishek Jaywant, PhD
abj2006@med.cornell.edu
646-289-5204
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov