A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05507138
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • AKL-T01 — DEVICE
    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 Training — BEHAVIORAL
    Metacognitive Strategy Training involves working with a clinician (neuropsychologist or occupational therapist) to learn strategies to manage cognitive difficulties

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CenterNew YorkNew York10065
Abhishek Jaywant, PhD
[email protected]
646-289-5204

Find similar trials in New York, NY

By condition
DepressionStroke
By specialty
PsychiatryMental healthBehavioral healthNeurologyBrain disorders
By research site
Weill Cornell Medical Center· New York, NY

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