Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment (SDST)
Primary Purpose
MCI, Subjective Cognitive Decline, Healthy Aging
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Senior Driving Simulation Training
Waiting list control
Sponsored by

About this trial
This is an interventional prevention trial for MCI focused on measuring driving simulation, executive function, brain wave
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental Group
Control Group
Arm Description
Senior Driving Simulation Training
Waiting-list
Outcomes
Primary Outcome Measures
Mental set shifting, measured by Wisconsin Card Sorting Test
Mental set shifting is one of the sub-categories of executive function
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
Working memory, measured by Digit span test
Working memory is one of the sub-categories of executive function
Change from Baseline Working memory, measured by Digit span test at 3 months
Working memory is one of the sub-categories of executive function
Inhibition, measured by the Stroop Color and Word Test
Inhibition is one of the sub-categories of executive function
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
Secondary Outcome Measures
Cognitive function measured by Montreal Cognitive Assessment
Cognitive function measured by Montreal Cognitive Assessment
Cognitive function measured by Cognitive Change Index(C-CCI)
Cognitive function measured by Cognitive Change Index(C-CCI)
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
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
EEG
EEG power in delta, theta, alpha, and beta band
Change from Baseline EEG at 3 months
EEG power in delta, theta, alpha, and beta band
Visual awareness measured by CANTAB
Visual awareness measured by CANTAB
Visual awareness measured by trail making test
Visual awareness measured by trail making test
Change from Baseline visual awareness by CANTAB at 3 months
Visual awareness measured by CANTAB
Change from Baseline visual awareness by trail making test at 3 months
Change from Baseline visual awareness by trail making test at 3 months
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05380284
Brief Title
Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment
Acronym
SDST
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
May 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MCI, Subjective Cognitive Decline, Healthy Aging
Keywords
driving simulation, executive function, brain wave
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Senior Driving Simulation Training
Arm Title
Control Group
Arm Type
Other
Arm Description
Waiting-list
Intervention Type
Other
Intervention Name(s)
Senior Driving Simulation Training
Intervention Description
The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .
Intervention Type
Other
Intervention Name(s)
Waiting list control
Intervention Description
The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.
Primary Outcome Measure Information:
Title
Mental set shifting, measured by Wisconsin Card Sorting Test
Description
Mental set shifting is one of the sub-categories of executive function
Time Frame
immediate post-test
Title
Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months
Description
Mental set shifting is one of the sub-categories of executive function
Time Frame
3 months follow-up
Title
Working memory, measured by Digit span test
Description
Working memory is one of the sub-categories of executive function
Time Frame
immediate post-test
Title
Change from Baseline Working memory, measured by Digit span test at 3 months
Description
Working memory is one of the sub-categories of executive function
Time Frame
3 months follow-up
Title
Inhibition, measured by the Stroop Color and Word Test
Description
Inhibition is one of the sub-categories of executive function
Time Frame
immediate post-test
Title
Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months
Description
Inhibition is one of the sub-categories of executive function
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Cognitive function measured by Montreal Cognitive Assessment
Description
Cognitive function measured by Montreal Cognitive Assessment
Time Frame
immediate post-test
Title
Cognitive function measured by Cognitive Change Index(C-CCI)
Description
Cognitive function measured by Cognitive Change Index(C-CCI)
Time Frame
immediate post-test
Title
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Description
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Time Frame
3 months follow-up
Title
Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
Description
Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
Time Frame
3 months follow-up
Title
EEG
Description
EEG power in delta, theta, alpha, and beta band
Time Frame
immediate post-test
Title
Change from Baseline EEG at 3 months
Description
EEG power in delta, theta, alpha, and beta band
Time Frame
3 months follow-up
Title
Visual awareness measured by CANTAB
Description
Visual awareness measured by CANTAB
Time Frame
immediate post-test
Title
Visual awareness measured by trail making test
Description
Visual awareness measured by trail making test
Time Frame
immediate post-test
Title
Change from Baseline visual awareness by CANTAB at 3 months
Description
Visual awareness measured by CANTAB
Time Frame
3 months follow-up
Title
Change from Baseline visual awareness by trail making test at 3 months
Description
Change from Baseline visual awareness by trail making test at 3 months
Time Frame
3 months follow-up
Title
simulator sickness
Description
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.
Time Frame
immediate post-test
Title
Usability
Description
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.
Time Frame
immediate post-test
Title
Acceptance
Description
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.
Time Frame
immediate post-test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huei-Ling Chiu
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment
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