Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 – 79
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Who this trial is looking for
This trial is looking for people who have had a stroke at least 6 months ago and experience depression and cognitive difficulties. Participants will use an iPad-based program and learn new cognitive strategies to help improve their symptoms.
Are You a Good Fit for This Trial?
Must be takingAntidepressants
You may be able to join if
I have had a first-time stroke at least 6 months ago.
I have problems with executive function as shown in a test.
I have been diagnosed with a Major Depressive Episode.
I have moderate depressive symptoms.
I can use an iPad and a pen.
I have been on a stable dose of antidepressant medication for at least 8 weeks.
I can follow all study requirements and commit to the study duration.
You may not be able to join if
I have severe speech problems that affect my understanding.
I have speech issues that make it hard to talk.
I have severe vision issues or neglect of one side of my body.
I am already in another cognitive rehabilitation program.
I do not speak English well.
I have a significant neurologic condition besides my stroke.
I have dementia that affects my daily living.
I have a history of psychosis or mania.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. …
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.
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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 M…
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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