Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment

Conditions
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MCI, Subjective Cognitive Decline, Healthy Aging

Intervention / Treatment
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* Other: Senior Driving Simulation Training
* Other: Waiting list control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Senior Driving Simulation Training | Other: Senior Driving Simulation Training<br>* The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .<br>|
| Other: Control Group<br>Ｗaiting-list | Other: Waiting list control<br>* The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental set shifting, measured by Wisconsin Card Sorting Test | Mental set shifting is one of the sub-categories of executive function | immediate post-test | 
| Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months | Mental set shifting is one of the sub-categories of executive function | 3 months follow-up | 
| Working memory, measured by Digit span test | Working memory is one of the sub-categories of executive function | immediate post-test | 
| Change from Baseline Working memory, measured by Digit span test at 3 months | Working memory is one of the sub-categories of executive function | 3 months follow-up | 
| Inhibition, measured by the Stroop Color and Word Test | Inhibition is one of the sub-categories of executive function | immediate post-test | 
| Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months | Inhibition is one of the sub-categories of executive function | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function measured by Montreal Cognitive Assessment | Cognitive function measured by Montreal Cognitive Assessment | immediate post-test | 
| Cognitive function measured by Cognitive Change Index(C-CCI) | Cognitive function measured by Cognitive Change Index(C-CCI) | immediate post-test | 
| Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months | Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months | 3 months follow-up | 
| Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months | Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months | 3 months follow-up | 
| EEG | EEG power in delta, theta, alpha, and beta band | immediate post-test | 
| Change from Baseline EEG at 3 months | EEG power in delta, theta, alpha, and beta band | 3 months follow-up | 
| Visual awareness measured by CANTAB | Visual awareness measured by CANTAB | immediate post-test | 
| Visual awareness measured by trail making test | Visual awareness measured by trail making test | immediate post-test | 
| Change from Baseline visual awareness by CANTAB at 3 months | Visual awareness measured by CANTAB | 3 months follow-up | 
| Change from Baseline visual awareness by trail making test at 3 months | Change from Baseline visual awareness by trail making test at 3 months | 3 months follow-up | 
| simulator sickness | Simulator Sickness Questionnaire (SSQ). The 16-item SSQ will be used to assess participants' sickness levels. This is the 4-point Likert scale (0 - None to 3 - Severe), and the higher total score reflects more severe sickness. | immediate post-test | 
| Usability | The System Usability Scale (SUS) will be used to access the usability, this scale consists of 10 items, and the higher total score reflects better usability. | immediate post-test | 
| Acceptance | The Technology Acceptance for Older Adults Scale will be used to access the acceptance, this scale consists of 17 items, and the higher total score reflects better acceptance. | immediate post-test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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driving simulation, executive function, brain wave