NCT05507138RecruitingPhase 2
A Digital Intervention for Post-Stroke Depression and Executive Dysfunction
Efficacy and Target Engagement of a Digital Intervention to Improve Depression and Executive Dysfunction After Stroke
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 16 Aug 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Stroke
- NCT number
- NCT05507138
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Mar 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- receptive aphasia as determined by a score of 2 or 3 on the NIH Stroke Scale \[NIHSS\] item 9 ("Best Language")
- severe visual impairment or hemispatial neglect (score of 3 on NIHSS item #3 or score of 2 on NIHSS item #11)
- 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).
- 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.
Other
- dysarthria that makes speech unintelligible (score of 2 on NIHSS item #10)
- non-fluency in English
- 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
- pregnancy
- any other clinical or medical reason in the PI's initial screening evaluation that suggests the study is not appropriate for the participant.
Who the study is looking for
- 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
Age in the registry: 50 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.