A Language-Based Training Intervention to Enhance Cognitive Health in Community-Dwelling Older Adults

NCT07132281 | Recruiting

• 1 other identifier: 202504009RIND
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Taiwan is fast approaching a super-aged society, making it urgent to bolster cognitive health in otherwise healthy older adults. This integrated project tackles that need with a language-centered intervention grounded in predictive-coding and active-inference theory. Over 12 weeks, community-dwelling adults aged 65 + join small-group reading-and-writing workshops that train them to actively predict, monitor, and revise linguistic information. Ninety volunteers are randomly allocated to an active language-prediction group, a passive reading group, or a hobby board-game control. Before and after the course, researchers collect behavioural tests, EEG, fMRI, and AI-based speech-language analytics to quantify gains and transfer effects across cognition, emotion, and daily function.

Conditions

Promoting Active Inference of Healthy Older Adults With Language Activity

Keywords

active inference; language; cognitive enhancement training; neuroscience; large language model

Outcome Measures

Primary Outcomes (38)

• Changes of neural functional activity during inferential processing

  Participants will undergo a Rule Inference fMRI task to infer underlying rules that map color configurations of circles in a triangular arrangement to a target color category within as few tries as possible under active or passive conditions. The goal for participants will be to infer the cue-category association rules using as few cues as possible. The primary outcome measure here is the degree of neural response estimate change in blood oxygen level dependent (BOLD) signal pre- and post-intervention.

  Week 0, Week 12

• Changes of overall accuracy during inferential processing

  Changes from pre- to post-intervention in participant overall accuracy in identifying latent rules in the Rule Inference fMRI task.

  Week 0, Week 12

• Changes of learning rate during inferential processing

  Changes from pre- to post-intervention in participant number of trials to criterion in the Rule Inference fMRI task.

  Week 0, Week 12

• Changes of strategic performance during inferential processing

  Changes from pre- to post-intervention in participant coefficients of expression of modeled response strategies in the Rule Inference fMRI task will be assessed.

  Week 0, Week 12

• Changes of functional electrical brain responses during reading

  Participants will undergo EEG language reading tasks in which participants were told to actively comprehend the sentence and to infer meanings for unknown pseudowords. The primary outcome measure here is the changes in N400 responses and anterior positive responses pre- and post-intervention.

  Week 0, Week 12

• Changes in the Montreal Cognitive Assessment (MoCA) score

  Pre- to post-intervention changes in participant MoCA score. Score range from 0 to 30 with higher scores indicating better cognitive ability.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Logical Memory I & II

  Score range 0 - 75. Higher score indicates better verbal episodic memory.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Face Memory

  Score range 0 - 48. Higher score indicates better visual face memory.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Verbal Paired Memory

  Score range 0 - 32. Higher score indicates better verbal memory and learning.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Family Pictures I & II

  Score range 0 - 64. Higher score indicates better visual memory and learning.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Word Lists I & II

  Score range 0 - 36. Higher score indicates better verbal memory and learning. For II, recall score range is 0 to 8; recognition score range is 0 to 24.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Visual Reproduction I & II

  Score range 0 - 104. Higher score indicates better visual memory. For II, recall score range is 0-104; recognition score range is 0-48.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Spatial Span

  Score range 0 - 32. Higher score indicates better spatial memory.

  Week 0, Week 12

• Change in Wechsler Memory Scale III Digit Span

  Score range 0 - 32. Higher score indicates better auditory memory.

  Week 0, Week 12

• Change in Wechsler Adult Intelligence Scale III Vocabulary

  Score range 0 - 66. Higher score indicates better vocabulary.

  Week 0, Week 12

• Change in Wechsler Adult Intelligence Scale III Digit Symbol

  Score range 0 - 133. Higher score indicates better processing speed.

  Week 0, Week 12

• Change in Wechsler Adult Intelligence Scale III Block Design

  Score range 0 - 68. Higher score indicates better visual processing.

  Week 0, Week 12

• Change in Wechsler Adult Intelligence Scale III Arithmetic

  Score range 0 - 22. Higher score indicates better mathematical computation ability.

  Week 0, Week 12

• Change in Wechsler Adult Intelligence Scale III Matrix Reasoning

  Score range 0 - 26. Higher score indicates better reasoning.

  Week 0, Week 12

• Changes of overall accuracy for meaning inferences

  Changes from pre- to post-intervention in participants' overall accuracy in judging the semantic relation between newly learned pseudo-words and their semantic associates.

  Week 0, Week 12

• Changes of electrical brain responses during the task switching experiment

  Participants will undergo an EEG task-switching paradigm in which they are instructed to make an odd/even judgment or a size judgment on presented numbers.

  Week 0, Week 12

• Changes of overall accuracy during the task-switching paradigm

  Changes from pre- to post-intervention in participants' switch cost, assessed through overall accuracy.

  Week 0, Week 12

• Changes of Originality in Alternate Use Test (AUT)

  Developed by Guilford et al. (1967), this tool serves as a quantitative measure for assessing creativity and divergent thinking. In under three minutes, participants are given common multipurpose items and are asked to creatively think of uses for these items on paper, such as various uses for a brick. The scoring of Originality measures the uniqueness of the response in comparison to others. For instance, an answer that only 1% of participants come up with scores 2 points; an answer given by 5% scores 1 point.

  Week 0, Week 12

• Changes in Chinese Remote Association Task (CRAT)

  The Chinese Remote Association Task is used to measure individuals' abilities in convergent thinking. The original developer of the Remote Associates Test (RAT) was Mednick (1962). The Chinese version of the Remote Associates Test was developed by Huang et al. (2012). In this test, participants are provided with three Chinese words (e.g., Taiwan, land, barrier), and they are required to find a fourth Chinese word that forms a meaningful association with all three given words (e.g., strait). The study consists 30 questions and includes two versions of the test, A and B, which have a correlation of 0.610. The internal consistency coefficients for these versions are 0.808 and 0.801, respectively （Ren et al., 2004).

  Week 0, Week 12

• Changes of completion time in Color Trails Test (CTT)

  Performance is measured by recording the completion time.

  Week 0, Week 12

• Changes of number of trials administered in Wisconsin Card Sorting Test (WCST)

  Participants' performance is evaluated by measuring total trials required to complete the task (fewer trials indicate better performance).

  Week 0, Week 12

• Changes of overall fluency of language production

  Changes from pre- to post-intervention in participants' fluency in language production.

  Week 0, Week 12

• Changes of the number of errors in Color Trails Test (CTT)

  The Color Trails Test (CTT) is a neuropsychological assessment designed to measure sustained attention, alternating attention, and executive functioning (D'Elia et al., 1996). The test typically takes between 3 and 8 minutes to complete and consists of two parts. In Part 1, participants are instructed to connect numbered circles (1 through 25) in ascending order as quickly as possible. In Part 2, participants must again connect the numbered circles in order but are required to alternate between pink and yellow circles, adding a set-shifting and divided attention component. Performance is measured by the number of errors for each part. This study employed the Chinese adaptation of the CTT developed by Guo (2009), which includes normative data for Chinese adults aged 50 to 88 years. The test-retest reliability coefficients for Part 1 and Part 2 were reported as 0.618 and 0.833, respectively.

  Week 0, Week 12

• Changes of Fluency in Alternate Use Test (AUT)

  Developed by Guilford et al. (1967), this tool serves as a quantitative measure for assessing creativity and divergent thinking. In under three minutes, participants are given common multipurpose items and are asked to creatively think of uses for these items on paper, such as various uses for a brick. The scoring of Fluency measures the total number of responses.

  Week 0, Week 12

• Changes of Flexibility in Alternate Use Test (AUT)

  Developed by Guilford et al. (1967), this tool serves as a quantitative measure for assessing creativity and divergent thinking. In under three minutes, participants are given common multipurpose items and are asked to creatively think of uses for these items on paper, such as various uses for a brick. The scoring of flexibility is as follow: Responses are categorized based on their characteristics, and the number of categories is counted as the score.

  Week 0, Week 12

• Changes of overall reaction time during the task-switching paradigm

  Changes from pre- to post-intervention in participants' switch cost, assessed through overall reaction time.

  Week 0, Week 12

• Changes of percent correct in Wisconsin Card Sorting Test (WCST)

  The proportion of trials with correct responses is measured.

  Week 0, Week 12

• Changes of percent errors in Wisconsin Card Sorting Test (WCST)

  The proportion of trials with incorrect responses is measured.

  Week 0, Week 12

• Changes of number of categories completed in Wisconsin Card Sorting Test (WCST)

  The number of sorting categories completed is measured (i.e., 10 consecutive correct responses per rule).

  Week 0, Week 12

• Changes of trials to complete first category in Wisconsin Card Sorting Test (WCST)

  The number of trials required to achieve the first sorting criterion is measured.

  Week 0, Week 12

• Changes of percent perseverative responses in Wisconsin Card Sorting Test (WCST)

  The percent perseverative responses that continued to follow the previous rule, regardless of correctness, is measured.

  Week 0, Week 12

• Changes of percent perseverative errors in Wisconsin Card Sorting Test (WCST)

  The proportion of incorrect responses due to perseveration (i.e., failure to shift after rule change) is measured.

  Week 0, Week 12

• Changes of percent nonperseverative errors in Wisconsin Card Sorting Test (WCST)

  The proportion of incorrect responses not attributable to perseveration is measured.

  Week 0, Week 12

Study Arms (3)

Active inference training

EXPERIMENTAL

Participants will undergo language activities and will be encouraged to actively infer based on the given language materials.

Behavioral: Language activities active inference

Step-by-Step Guidance

ACTIVE COMPARATOR

Participants will undergo language activities and will receive step-by-step guidance.

Behavioral: Language activities passive

Board Games

PLACEBO COMPARATOR

Participants will play boards games under a schedule matching the Experimental and Active Comparator arms.

Behavioral: Board Games

Interventions

Language activities active inference BEHAVIORAL

Participants will join reading or writing activities and come up with their own inference about wording or plots.

Active inference training

Language activities passive BEHAVIORAL

Participants will join reading or writing activities and will be given step-by-step explanations about the wording and plots.

Step-by-Step Guidance

Board Games BEHAVIORAL

Participants will play board games with each other.

Board Games

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 20 and 30 (healthy young adults) or aged 65 and above (healthy older adults).
• Native Mandarin Chinese speakers who had no exposure to non-indigenous languages before the age of five.
• Have completed at least a junior high school level of education.
• Right-handed.
• Have normal or corrected-to-normal vision (e.g., through glasses or contact lenses).
• Able to fully participate in the entire assessment and intervention schedule (with no more than two missed intervention sessions).
• Achieve a score of 23 or higher on the Montreal Cognitive Assessment (MoCA).

You may not qualify if:

• Participation in another cognitive intervention program within the past two months.
• Cognitive intervention is not feasible due to dyslexia or physical illness. Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia.
• Presence of severe depression, or cognitive changes caused by other psychiatric, neurological disorders, or substance abuse, with symptoms that are unstable or interfere with functioning.
• History of brain injury or neurological conditions (e.g., stroke, aneurysm).
• Contraindications for MRI scanning, such as metal implants, pacemakers, or pregnancy.
• Claustrophobia (an anxiety disorder characterized by panic symptoms or fear of panic attacks in enclosed spaces such as elevators, vehicles, tunnels, or airplane cabins).
• Unable to undergo cognitive assessments due to visual or hearing impairments.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 106319, Taiwan

RECRUITING

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

Communication; Behavior

Central Study Contacts

Chia-Lin Lee, Ph.D.

CONTACT

886-921-364-008; Chialinlee@ntu.edu.tw

Chia-Lin Lee, Ph.D.

CONTACT

886-2-3366-1972

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 20, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available 1 year after primary results are published by the central research team. Data are anticipated to be available for sharing for an indefinite period after the above criteria is met.
• Access Criteria: Data sharing will be done based direct requests and on case-by-case evaluation for appropriateness. Use of shared data will require agreement on appropriate citation of data sources at least or authorship inclusion or acknowledgement.

Locations

TW (1)