Smartphone program to test brain health in people at high stroke risk
Tests a smartphone health program in adults aged 40 or older at high stroke risk.
Plain-language title generated from the registry record
Registry title: Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
Key facts
- Where
- Hangzhou, ChinaSee the site
Where in China
- Second Affilated Hospital of Zhejiang University, School of MedicineHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07092371
- Record updated
- 29 July 2025
- Original description
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.Read full original descriptionShow less
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
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.
Inclusion: 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: previously diagnosed dementia; Previous history of major head trauma and any intracranial surgery; Participation in an ongoing investigational drug study; Exit Criteria:; Suspected dementia after clinical assessment by study physician at screening visit; Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions; Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement; Patients presenting a malignant disease with life expectancy < 3 years; Severe loss of vision, hearing, or communicative ability; 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.