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Effect of a fNIRS-based Personalized Multi-domain Intervention on Cognitive in Elderly Population With High Risk of Stroke

NCT05930249 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-07-05

No results posted yet for this study

Summary

This functional near-infrared spectroscopy-based personalized multidomain intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 years old persons with high risk of stroke in China. The primary outcome is 6-months change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on functional near-infrared spectroscopy will prevent cognitive decline by the initial 6-months intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 2 years' follow-up. The investigators hypothesize that the functional near-infrared spectroscopy-based personalized intervention may reduce the 2-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, social activity, and cognitive training activities.

Conditions

Interventions

BEHAVIORAL

Personalized multidomain intervention

1. Patients will complete personalized cognitive training based on baseline fNIRS on APP (20-30 mins/day, 3-4 days/week, 6 months). 2. Shared decision-making on risk factor of stroke between doctors and patients 3. Social support by grouping patients online to ensure close interaction with other patients in the same arm

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930249 on ClinicalTrials.gov