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Can an iPad app lift mood and sharpen mind after stroke?
NCT ID NCT05507138
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests whether a digital program on an iPad, combined with learning thinking strategies, can improve mood and mental skills in people who have had a stroke. The study will include 70 adults who had a first stroke at least 6 months ago and now have depression and trouble with focus or memory. Participants will use the iPad program and be compared to a control group to see if their thinking, mood, and daily life get better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Weill Cornell Medical Center
RECRUITINGNew York, New York, 10065, United States
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