NCT07092371Not yet recruiting
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
Source: ClinicalTrials.gov · Last updated 29 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1036 (estimated)
- First submitted
- 12 May 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Stroke
- NCT number
- NCT07092371
What you commit to
- Study type: Interventional
- Planned participants: 1036
- From 1 Aug 2025 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously diagnosed dementia
- Previous history of major head trauma and any intracranial surgery
- Participation in an ongoing investigational drug study
- Exit Criteria:
Other illness
- 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
Age
- Patients presenting a malignant disease with life expectancy \< 3 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affilated Hospital of Zhejiang University, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.