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Clinical Trials in China / NCT07092371
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Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)

NCT07092371 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-08-01
Last updated
2025-07-29

Condition(s) studied

Cognitive ImpairmentDementiaArtificial Intelligence (AI)StrokeCognitive Decline

Investigational drug(s) / intervention(s)

Digital Multimodal Intervention

Digital Multimodal Intervention: Participants will undergo a 6-month multimodal intervention via a digital platform, which includes: (1) Personalized cognitive training; (2) Self-monitoring and management of stroke risk factors including hypertension, dyslipidemia, diabetes, smoking and obesity; (3) Smart wristband-based exercise monitoring and management; (4) Smart wristband-based sleep monitoring and management; (5) Health dietary recording and guidance

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Second Affilated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07092371 on ClinicalTrials.gov ↗ ← All trials in China