Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) (NCT07092371) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
China1,036 participantsStarted 2025-08-01
Plain-language summary
This randomized controlled trial will enroll individuals aged ≥ 40 years without dementia who are at high risk for stroke, collecting multi-modal MRI imaging, serum, and fecal samples to investigate the effects of a smartphone-based multimodal health intervention on cognitive function measured using digital-evaluated cognitive scores.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* Patients aged ≥ 40 years
* High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
* Written informed consent available
* Primary school education or above
* Proficient in using smartphones
* Willingness to complete all assessments and participate in follow-up
Exclusion Criteria:
* previously diagnosed dementia
* Suspected dementia after clinical assessment by study physician at screening visit
* Previous history of major head trauma and any intracranial surgery
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* Severe loss of vision, hearing, or communicative ability
* Patients presenting a malignant disease with life expectancy \< 3 years
* Participation in an ongoing investigational drug study
Exit Criteria:
* Not meet the inclusion criteria
* For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
* Any adverse or serious adverse events during the study period judged by Investigator
What they're measuring
1
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol
Timeframe: 6 months
Trial details
NCT IDNCT07092371
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University