Your session is about to expire
← Back to Search
Digital Intervention + Cognitive Strategies for Post-Stroke Depression
Phase 2
Recruiting
Led By Abhishek Jaywant, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of treatment (6 weeks)
Awards & highlights
Study Summary
This trial will test whether a digital therapeutic combined with learning cognitive strategies can help improve cognition, depression, daily function, and brain connectivity in stroke survivors.
Who is the study for?
This trial is for individuals who had their first stroke at least 6 months ago and are now experiencing moderate depression and executive dysfunction. They must be able to use an iPad, not have severe language or speech impairments, no major neurological conditions other than stroke, and if on antidepressants, they should be on a stable dose for at least 8 weeks.Check my eligibility
What is being tested?
The study tests a digital therapeutic (iPad-based cognitive training) combined with metacognitive strategy training. It aims to improve cognitive skills, alleviate symptoms of depression, enhance daily functioning, and potentially affect brain connectivity in post-stroke patients.See study design
What are the potential side effects?
Since this intervention involves non-pharmaceutical therapy (digital cognitive exercises), typical drug side effects are not expected. However, participants may experience frustration or fatigue from the mental effort required by the tasks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and end of treatment (6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of treatment (6 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in executive function, as measured by the Oral Symbol Digit Modalities Test (SDMT)
Secondary outcome measures
Magnetic Resonance Imaging
Change in daily function, as measured by the Neuro Quality of Life (NeuroQOL) Cognitive Function Short Form
Change in daily function, as measured by the performance-based Weekly Calendar Planning Activity (WCPA)
+4 moreSide effects data
From 2023 Phase 2 trial • 110 Patients • NCT048439304%
Dizziness
2%
Headache
2%
Planned surgery
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
AKL-T01 Intervention
Waitlist Control
Control Arm Participants Who Started AKL-T01 Intervention
Control Arm Participants Who Declined AKL-T01 Intervention
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AKL-T01Experimental Treatment2 Interventions
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.
Group II: Enhanced Metacognitive Strategy TrainingPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AKL-T01
2018
Completed Phase 2
~860
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,482 Total Patients Enrolled
66 Trials studying Depression
16,328 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,205 Total Patients Enrolled
666 Trials studying Depression
251,514 Patients Enrolled for Depression
Abhishek Jaywant, PhDPrincipal InvestigatorWeill Medical College of Cornell University
3 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe mental illness like psychosis or mania.You have severe problems with seeing or paying attention to half of your visual field.I have a significant neurological condition, but not a stroke.I need help with daily activities because of memory loss.My speech is hard to understand due to a medical condition.I have been on the same dose of antidepressant for at least 8 weeks.You have significant symptoms of depression, as measured by a specific scale, called the Montgomery Asberg Depression Rating Scale, with a score of 18 or higher.You have severe depression, even without thinking about hurting yourself, that requires more intensive care or immediate help from a mental health doctor.My first stroke happened at least 6 months ago.You have trouble with tasks that involve planning and organizing, as shown by a test score that is much lower than average for your age.You are currently participating in a cognitive rehabilitation program at the same time as this study. However, if you are in psychotherapy, this will not prevent you from participating.You have a serious problem with thinking and decision-making that would make it difficult for you to use the iPad during the screening evaluation.You are able to use an iPad and a pen without any difficulty.I am not fluent in English.You have trouble understanding or speaking because of a stroke.You have thoughts of hurting yourself, as determined by a specific test.You have been diagnosed with a major depressive episode using a specific interview assessment called SCID.My first stroke happened at least 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: AKL-T01
- Group 2: Enhanced Metacognitive Strategy Training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the eligibility criteria for this research project restricted to those above 55 years of age?
"In accordance with the study's terms, candidates must be between 50 and 79 years old to be eligible for participation."
Answered by AI
To what degree is AKL-T01 considered a secure treatment for patients?
"The safety of AKL-T01 has been evaluated with a score of 2, as there is some evidence to suggest its security but the efficacy of this medication remains untested."
Answered by AI
Are there available slots for participants for this experiment?
"The clinicaltrials.gov data confirms this trial is not presently recruiting, as it was last updated November 18th 2022 since its initial posting on January 1st 2023. Nonetheless, 2332 other trials are currently accepting participants at the present time."
Answered by AI
Could I potentially qualify for participation in this scientific experiment?
"This clinical trial will feature 70 individuals aged 50 to 79 suffering from depression. In order to be considered, applicants must fulfill the following criteria: a first-time stroke that transpired not less than 6 months prior to commencement of the study; executive dysfunction measured with scores below 1 standard deviation on at least one test of executive function during screening evaluation; Montgomery Asberg Depression Rating Scale score measuring ≥18 for moderate depressive symptoms; motor ability adequate enough to operate an iPad and utilize a pen (as judged by self-report and observation); if administered antidepressant medication, should have been taking it in stable doses for minimum 8 weeks before enrollment into this study;"
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Weill Cornell Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger