Clinical trial NCT05380284: Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment
Official title: Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MCI
Subjective Cognitive Decline
Healthy Aging
Keywords: driving simulation
executive function
brain wave
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG.

Detailed description: Driving behavior is a high cognitively demanding task, and whether the Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) can continue to drive is an important issue. This study will develop the Taiwan version of innovative, immediate feedback and environmentally safe Senior Driving Simulation Training (SDST). This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG. The investigators intend to conduct a single-blind randomized controlled trial using a two-arm parallel-group design. Participants will be randomized by the permuted block randomization, block size of 4, into an experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) or a control group (Waiting list). The investigators plan to blind the therapists and outcome assessors to maintain the blinding methods' quality. The primary outcome indicators are mental set-shifting, working memory, and inhibition. The secondary outcome indicators are cognitive function and EEG. The investigators also evaluate visual awareness and simulator sickness. The short-term (immediate post-test) and the long-term (3, 6, and 12 months) effectiveness of the intervention on individual outcome measures will be analyzed by the generalized estimating equation. The investigators also plan to use the secondary data analysis methods to investigate the relationship between objective indicators of a driving simulator, executive function, cognitive function, EEG, visual awareness, and simulator sickness. Furthermore, the investigators will analyze the trend of EEG while the participants conducting the training, and complete the psychometric properties of the Chinese version of the Cognitive Change Index (C-CCI). This will be the first senior driving simulation training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) in Taiwan. Results of the current study will provide valuable information on driving safety decisions and apply to promote the advanced driving policies.

Eligibility criteria: Inclusion Criteria:

* Subjective cognitive decline( AD-8 scale ≥1 point).
* Mild cognitive impairment (AD-8 scale ≥ 2 points), and MMSE\> 24 points, can maintain personal daily activity function.
* Can communicate in Chinese or Taiwanese.
* At least 60 years of age.
* Those with a car driving license.
* No physical impairment.
* In addition to the above conditions, participants must be voluntary and signed informed consent.

Exclusion Criteria:

* Dementia, diagnosed by a physician and in compliance with ICD-10.
* Significant mental illness or communication impairment.

Primary outcomes:
measure: Mental set shifting, measured by Wisconsin Card Sorting Test
timeFrame: immediate post-test
measure: Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months
timeFrame: 3 months follow-up
measure: Working memory, measured by Digit span test
timeFrame: immediate post-test
measure: Change from Baseline Working memory, measured by Digit span test at 3 months
timeFrame: 3 months follow-up
measure: Inhibition, measured by the Stroop Color and Word Test
timeFrame: immediate post-test
measure: Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months
timeFrame: 3 months follow-up
Secondary outcomes:
measure: Cognitive function measured by Montreal Cognitive Assessment
timeFrame: immediate post-test
measure: Cognitive function measured by Cognitive Change Index(C-CCI)
timeFrame: immediate post-test
measure: Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
timeFrame: 3 months follow-up
measure: Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
timeFrame: 3 months follow-up
measure: EEG
timeFrame: immediate post-test
measure: Change from Baseline EEG at 3 months
timeFrame: 3 months follow-up
measure: Visual awareness measured by CANTAB
timeFrame: immediate post-test
measure: Visual awareness measured by trail making test
timeFrame: immediate post-test
measure: Change from Baseline visual awareness by CANTAB at 3 months
timeFrame: 3 months follow-up
measure: Change from Baseline visual awareness by trail making test at 3 months
timeFrame: 3 months follow-up
measure: simulator sickness
timeFrame: immediate post-test
measure: Usability
timeFrame: immediate post-test
measure: Acceptance
timeFrame: immediate post-test
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Huei-Ling Chiu
role: PRINCIPAL_INVESTIGATOR
References: