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

NCT05930249 | Unknown

• 1 other identifier: FNIRS
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Cognitive Impairment; Stroke; Dementia

Outcome Measures

Primary Outcomes (1)

• Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol

  Primary Outcome

  6 months

Secondary Outcomes (18)

• Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition

  6 months

• Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition

  2 year

• Cognitive function change assessed by Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

  6 months

• Cognitive function change assessed by Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

  2 year

• Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

  6 months

Study Arms (2)

Standard health counseling

NO INTERVENTION

Personalized multidomain intervention

EXPERIMENTAL

Behavioral: Personalized multidomain intervention

Interventions

Personalized multidomain intervention BEHAVIORAL

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

Personalized multidomain intervention

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 45-74 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)

You may not qualify if:

• previously diagnosed dementia
• previously diagnosed stroke (both cerebral infarction and hemorrhage)
• suspected dementia after clinical assessment by study physician at screening visit
• Mini-mental State Examination \[MMSE\] score\<20
• disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularization within 1 year previously)
• severe loss of vision, hearing, or communicative ability
• disorders preventing cooperation as judged by the study physician
• coincident participation in another intervention trial
• any MRI contraindications

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Min Lou

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 5, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

CN (1)