Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population

A Study of Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population

The global population is aging rapidly, with the number of elderly people with dementia projected to rise sharply, posing significant challenges to quality of life and societal burden.Frequent language switching, such as in interpreting, enhances cognitive abilities by improving attention, flexibility, and memory.Dialect-switching training, similar to interpreting, is a non-invasive method that shows potential for promoting cognitive health in the elderly but remains under-researched.This study aims to investigate the cognitive-enhancing effects of a dialect-switching training program on older adults with vascular risk factors through a six-month intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Cognitive Impairment No Dementia
• Intervention / Treatment: Behavioral: Dialect Interpreting Training

Detailed Description

The global population is aging rapidly, with those aged 65+ expected to reach 16% of the total population by 2050. Aging is linked to increased cognitive impairment risks, including dementia prevalence rates of 5%-10% among the elderly in developed countries. In China, the number of elderly with dementia is projected to soar from 7.4 million to 18 million by 2030 without intervention. This trend poses significant challenges to quality of life and societal burden.

Language experiences, particularly frequent switching between languages, enhance cognitive abilities. Interpreting, which demands high-intensity language switching, significantly improves cognitive control and memory. Interpreters' need for rapid language conversion and reliance on attention, flexibility, and inhibition contribute to their cognitive advantages.

Similar to interpreting, switching between dialects and standard language requires high-frequency, high-intensity language conversion. This non-invasive training method is suitable for promoting cognitive health in the elderly. However, its potential benefits for cognitive enhancement in this population remain underexplored.

This study aims to design a dialect-switching training program simulating interpreting and investigate its potential cognitive-enhancing effects through a six-month intervention in older adults with vascular risk factors.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 057187783777; Email: lm99@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged ≥ 60 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)
• command of Hangzhou dialect
• Written informed consent available
• Willingness to complete all assessments and participate in follow-up
• Adequate Visual and auditory acuity to undergo neuropsychological testing

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
• Any MRI contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Rountine; The control group will not receive any language intervention training and will maintain their usual daily routines.
Experimental: Dialect Interpreting Training; The intervention group will receive a combination of offline and online language-switching training. The offline intervention will last for 2 months, with three training sessions per week, each lasting 1 hour. The training content will simulate the interpreting process, requiring participants to switch and convert rapidly and accurately between two dialects, covering multiple aspects including listening comprehension, oral expression, and information processing. The online intervention will last for 4 months, during which participants will regularly complete exercises through a language training app or website and upload their assignments.	Behavioral: Dialect Interpreting Training; The intervention group will receive a combination of offline and online language-switching training. The offline intervention will last for 2 months, with three training sessions per week, each lasting 1 hour. The training content will simulate the interpreting process, requiring participants to switch and convert rapidly and accurately between two dialects, covering multiple aspects including listening comprehension, oral expression, and information processing. The online intervention will last for 4 months, during which participants will regularly complete exercises through a language training app or website and upload their assignments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)	Primary Outcome	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	short-term secondary outcome	6 months
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	short-term secondary outcome	6 months
Changes in brain functional network efficiency assessed by resting state fMRI	long-term secondary outcome	2 years
Changes in brain functional network activity intensity assessed by resting state fMRI	long-term secondary outcome	2 years
Changes in brain functional network efficiency assessed by resting state fMRI	long-term secondary outcome	5 years
Changes in brain functional network activity intensity assessed by resting state fMRI	long-term secondary outcome	5 years
Changes in brain functional network efficiency assessed by resting state fMRI	short-term secondary outcome	6 months
Changes in brain functional network activity intensity assessed by resting state fMRI	short-term secondary outcome	6 months
Changes in brain functional network connectivity assessed by resting state fMRI	long-term secondary outcome	2 years
Changes in brain functional network connectivity assessed by resting state fMRI	long-term secondary outcome	5 years
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 (NINDS-CSN) protocol (higher scores mean a better outcome)	short-term secondary outcome	6 months
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 (NINDS-CSN) protocol (higher scores mean a better outcome)	long-term secondary outcome	2 years
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 (NINDS-CSN) protocol (higher scores mean a better outcome)	long-term secondary outcome	5 years
Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)	short-term secondary outcome	6 months
Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)	long-term secondary outcome	2 years
Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)	long-term secondary outcome	5 years
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	short-term secondary outcome	6 months
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	2 years
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	5 years
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	2 years
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	5 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence	short-term secondary outcome	6 months
Changes in lacunes assessed on MRI with T2 FLAIR sequence	short-term secondary outcome	6 months
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence	short-term secondary outcome	6 months
Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence	short-term secondary outcome	6 months
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI	short-term secondary outcome	6 months
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	2 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	5 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	2 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	5 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	2 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	5 years
Changes in microbleeds assessed on MRI with SWI sequence sequence	long-term secondary outcome	2 years
Changes in microbleeds assessed on MRI with SWI sequence sequence	long-term secondary outcome	5 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI	long-term secondary outcome	2 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI	long-term secondary outcome	5 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	long-term secondary outcome	2 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	long-term secondary outcome	5 years
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image	short-term secondary outcome	6 months
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image	long-term secondary outcome	2 years
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image	long-term secondary outcome	5 years
Metabolite profiles in participants' faecal samples and serum samples	short-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)	6 months
Metabolite profiles in participants' faecal samples and serum samples	long-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)	2 years
Incidence of stroke event including ischemic and hemorrhagic stroke	short-term secondary outcome	6 months
Incidence of stroke event including ischemic and hemorrhagic stroke	long-term secondary outcome	2 years
Incidence of stroke event including ischemic and hemorrhagic stroke	long-term secondary outcome	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: BOOST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No