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Search / Trial NCT07092371

Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jul 22, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Stoke Cognitive Impairment Cognitive Decline Dementia Artificial Intelligence (Ai)

ClinConnect Summary

This clinical trial, called SHINE, is studying whether a smartphone-based health program can help protect thinking skills in people who are at high risk for stroke but do not have dementia. The researchers will use brain scans and collect blood and stool samples to better understand how this program might improve memory and thinking abilities over time, using simple digital tests on the phone.

People aged 40 and older who have at least three common stroke risk factors—such as high blood pressure, diabetes, smoking, obesity, or a family history of stroke—may be eligible to join. Participants need to be comfortable using a smartphone and willing to complete all the study activities and follow-up visits. During the trial, participants will use the smartphone program and undergo regular assessments to track their cognitive health. This study is not yet recruiting but aims to find new ways to help people maintain brain health and reduce the chances of cognitive decline after stroke risk.

Gender

ALL

Eligibility criteria

  • 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

About Second Affiliated Hospital, School Of Medicine, Zhejiang University

The Second Affiliated Hospital of Zhejiang University School of Medicine is a leading clinical research institution dedicated to advancing healthcare through innovative medical practices and rigorous scientific inquiry. With a robust infrastructure and a multidisciplinary team of experienced researchers and clinicians, the hospital is committed to conducting high-quality clinical trials that address critical health challenges. As an integral part of Zhejiang University, the hospital leverages academic expertise and cutting-edge technology to foster collaboration in research, education, and patient care, ultimately aiming to improve patient outcomes and contribute to the global medical community.

Locations

Hangzhou, Zhejiang, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported