NCT05507138 A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
| NCT ID | NCT05507138 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Executive Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2023-03-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * patient already enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is already enrolled in psychotherapy, this will not be grounds for exclusion) * 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.
Contact & Investigator
Abhishek Jaywant, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05507138 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 79 Years, studying Executive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05507138 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05507138 currently recruiting?
Yes, NCT05507138 is actively recruiting participants. Contact the research team at alk4028@med.cornell.edu for enrollment information.
Where is the NCT05507138 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05507138 clinical trial?
NCT05507138 is sponsored by Weill Medical College of Cornell University. The principal investigator is Abhishek Jaywant, PhD at Weill Medical College of Cornell University. The trial plans to enroll 70 participants.