A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

NCT05507138 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: 21-110241591K23MH129849-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Executive Dysfunction; Depression; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)

  Change in score in the active intervention arm vs. the comparator arm on the SDMT, a performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.

  Baseline and end of treatment (6 weeks)

Secondary Outcomes (7)

• Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)

  Baseline and end of treatment (6 weeks)

• Change in depression symptoms, as measured by the 9-item Patient Health Questionnaire (PHQ-9)

  Baseline and end of treatment (6 weeks)

• Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form

  Baseline and end of treatment (6 weeks)

• Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA)

  Baseline and end of treatment (6 weeks)

• Change in connectivity in the executive control network, as assessed by resting state functional MRI (rs-fMRI).

  Baseline and end of treatment (6 weeks)

Study Arms (2)

AKL-T01

EXPERIMENTAL

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.

Device: AKL-T01; Behavioral: Metacognitive Strategy Training

Enhanced Metacognitive Strategy Training

PLACEBO COMPARATOR

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.

Behavioral: Metacognitive Strategy Training

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.

AKL-T01

Metacognitive Strategy Training BEHAVIORAL

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

AKL-T01; Enhanced Metacognitive Strategy Training

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• receptive aphasia as determined by a score of 2 or 3 on the NIH Stroke Scale \[NIHSS\] item 9 ("Best Language")
• dysarthria that makes speech unintelligible (score of 2 on NIHSS item #10)
• severe visual impairment or hemispatial neglect (score of 3 on NIHSS item #3 or score of 2 on NIHSS item #11)
• non-fluency in English
• presence of or history of significant neurologic or neurodegenerative disorder other than stroke
• presence of dementia based on dependence in basic ADLs due to cognitive deficits
• history of psychosis or mania (evaluated using the SCID).
• active suicide ideation (assessed via the Columbia Suicide Severity Rating Scale)
• severe executive dysfunction (based on clinical judgment during screening evaluation) precluding use of the iPad
• severe depression-even in the absence of active suicidal ideation-based on the screening evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services.
• pregnancy
• any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Depression; Stroke

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Abhishek Jaywant, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Keenan, BS

CONTACT

212-746-1509; alk4028@med.cornell.edu

Abhishek Jaywant, PhD

CONTACT

646-289-5204; abj2006@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and clinicians conducting the metacognitive strategy coaching will be instructed not to reveal the group assignment to the member of the research team conducting assessments. Following the completion of recruitment, data will be labelled as "Group A" and "Group B" to avoid bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the AKL-T01 intervention plus weekly metacognitive strategy coaching (intervention arm) or to weekly metacognitive strategy coaching plus general cognitive stimulation games such as word searches and other puzzles (control arm).

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: We will follow our institution's Data Retention Policy, which dictates that data be made available within three years of closeout of project/grant or upon publication, and that it is available for at least six years, with an additional six years if self-cited.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. All researchers requesting data will commit to using the data solely for research purposes; will have data shared that are pertinent to their research question/hypotheses; secure the data; return or destroy it once analyses are completed; do not share it with other researchers.

Locations

US (1)