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NCT Number: NCT06898931

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.

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Key information

Conditions

Vascular Cognitive Impairment no Dementia

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialect Interpreting Training

Behavioral

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.

Primary outcomes

  1. Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)

    Time frame: 6 months

    Primary Outcome

Secondary outcomes

  1. Changes in brain functional network efficiency assessed by resting state fMRI

    Time frame: 2 years

    long-term secondary outcome

  2. Changes in brain functional network activity intensity assessed by resting state fMRI

    Time frame: 2 years

    long-term secondary outcome

  3. Changes in brain functional network efficiency assessed by resting state fMRI

    Time frame: 5 years

    long-term secondary outcome

  4. Changes in brain functional network activity intensity assessed by resting state fMRI

    Time frame: 5 years

    long-term secondary outcome

  5. Changes in brain functional network efficiency assessed by resting state fMRI

    Time frame: 6 months

    short-term secondary outcome

  6. Changes in brain functional network activity intensity assessed by resting state fMRI

    Time frame: 6 months

    short-term secondary outcome

  7. Changes in brain functional network connectivity assessed by resting state fMRI

    Time frame: 2 years

    long-term secondary outcome

  8. Changes in brain functional network connectivity assessed by resting state fMRI

    Time frame: 5 years

    long-term secondary outcome

  9. 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)

    Time frame: 6 months

    short-term secondary outcome

  10. 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)

    Time frame: 2 years

    long-term secondary outcome

  11. 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)

    Time frame: 5 years

    long-term secondary outcome

  12. 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)

    Time frame: 6 months

    short-term secondary outcome

  13. 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)

    Time frame: 2 years

    long-term secondary outcome

  14. 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)

    Time frame: 5 years

    long-term secondary outcome

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

    Time frame: 6 months

    short-term secondary outcome

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

    Time frame: 2 years

    long-term secondary outcome

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

    Time frame: 5 years

    long-term secondary outcome

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

    Time frame: 6 months

    short-term secondary outcome

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

    Time frame: 2 years

    long-term secondary outcome

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

    Time frame: 5 years

    long-term secondary outcome

  21. Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence

    Time frame: 6 months

    short-term secondary outcome

  22. Changes in lacunes assessed on MRI with T2 FLAIR sequence

    Time frame: 6 months

    short-term secondary outcome

  23. Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

    Time frame: 6 months

    short-term secondary outcome

  24. Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence

    Time frame: 6 months

    short-term secondary outcome

  25. Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

    Time frame: 6 months

    short-term secondary outcome

  26. Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence

    Time frame: 2 years

    long-term secondary outcome

  27. Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence

    Time frame: 5 years

    long-term secondary outcome

  28. Changes in lacunes assessed on MRI with T2 FLAIR sequence

    Time frame: 2 years

    long-term secondary outcome

  29. Changes in lacunes assessed on MRI with T2 FLAIR sequence

    Time frame: 5 years

    long-term secondary outcome

  30. Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

    Time frame: 2 years

    long-term secondary outcome

  31. Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

    Time frame: 5 years

    long-term secondary outcome

  32. Changes in microbleeds assessed on MRI with SWI sequence sequence

    Time frame: 2 years

    long-term secondary outcome

  33. Changes in microbleeds assessed on MRI with SWI sequence sequence

    Time frame: 5 years

    long-term secondary outcome

  34. Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

    Time frame: 2 years

    long-term secondary outcome

  35. Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

    Time frame: 5 years

    long-term secondary outcome

  36. Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

    Time frame: 6 months

    short-term secondary outcome

  37. Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

    Time frame: 2 years

    long-term secondary outcome

  38. Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

    Time frame: 5 years

    long-term secondary outcome

  39. Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

    Time frame: 6 months

    short-term secondary outcome

  40. Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

    Time frame: 2 years

    long-term secondary outcome

  41. Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

    Time frame: 5 years

    long-term secondary outcome

  42. Metabolite profiles in participants' faecal samples and serum samples

    Time frame: 6 months

    short-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)

  43. Metabolite profiles in participants' faecal samples and serum samples

    Time frame: 2 years

    long-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)

  44. Incidence of stroke event including ischemic and hemorrhagic stroke

    Time frame: 6 months

    short-term secondary outcome

  45. Incidence of stroke event including ischemic and hemorrhagic stroke

    Time frame: 2 years

    long-term secondary outcome

  46. Incidence of stroke event including ischemic and hemorrhagic stroke

    Time frame: 5 years

    long-term secondary outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, PhD, MD

CONTACT

[email protected]

057187783777

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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