MCISDSTNCT05380284
Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment
A study testing Senior Driving Simulation Training in people with MCI and Subjective Cognitive Decline, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- MCI, Subjective Cognitive Decline, Healthy Aging
- What is being tested?
- Senior Driving Simulation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2022to 28 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia, diagnosed by a physician and in compliance with ICD-10.
- Significant mental illness or communication impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- MCI, Subjective Cognitive Decline, Healthy Aging
- Being tested
- Senior Driving Simulation Training, Waiting list control
- Keywords
- driving simulation, executive function, brain wave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior Driving Simulation TrainingOther
The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .
Waiting list controlOther
The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Senior Driving Simulation Training Receives: Other: Senior Driving Simulation Training |
| Control Group | Other | Ｗaiting-list Receives: Other: Waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental set shifting, measured by Wisconsin Card Sorting Test
Mental set shifting is one of the sub-categories of executive function
Measured: 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
Measured: 3 months follow-up
Working memory, measured by Digit span test
Working memory is one of the sub-categories of executive function
Measured: 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
Measured: 3 months follow-up
Inhibition, measured by the Stroop Color and Word Test
Inhibition is one of the sub-categories of executive function
Measured: 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
Measured: 3 months follow-up
Secondary outcomes (13)
Cognitive function measured by Montreal Cognitive Assessment
Cognitive function measured by Montreal Cognitive Assessment
Measured: immediate post-test
Cognitive function measured by Cognitive Change Index(C-CCI)
Cognitive function measured by Cognitive Change Index(C-CCI)
Measured: 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
Measured: 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
Measured: 3 months follow-up
EEG
EEG power in delta, theta, alpha, and beta band
Measured: immediate post-test
Change from Baseline EEG at 3 months
EEG power in delta, theta, alpha, and beta band
Measured: 3 months follow-up
Visual awareness measured by CANTAB
Visual awareness measured by CANTAB
Measured: immediate post-test
Visual awareness measured by trail making test
Visual awareness measured by trail making test
Measured: immediate post-test
Change from Baseline visual awareness by CANTAB at 3 months
Visual awareness measured by CANTAB
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediate post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start28 Jun 2022
- Primary completion1 Jan 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huie-Ling Chiu, Taipei Medical University
- Investigators
- Huei-Ling Chiu, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380284
- Sponsor's protocol ID
- N202002083
- Acronym
- SDST
- Status last verified
- May 2023
- First submitted
- 30 Apr 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05380284
- Acronym / sponsor ID
- SDST / N202002083
- Conditions
- MCI, Subjective Cognitive Decline, Healthy Aging
- Keywords
- driving simulation, executive function, brain wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Senior Driving Simulation TrainingSenior Driving Simulation Training |
| Control Group | Other | Other: Waiting list controlＷaiting-list |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Dementia, diagnosed by a physician and in compliance with ICD-10.
- Significant mental illness or communication impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senior Driving Simulation TrainingThe experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) . | Other | Experimental Group |
| Waiting list controlThe control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done. | Other | Control Group |
Primary outcome
Mental set shifting, measured by Wisconsin Card Sorting Test
Time frame: immediate post-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
Time frame: 3 months follow-up
Mental set shifting is one of the sub-categories of executive function
Working memory, measured by Digit span test
Time frame: immediate post-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
Time frame: 3 months follow-up
Working memory is one of the sub-categories of executive function
Inhibition, measured by the Stroop Color and Word Test
Time frame: immediate post-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
Time frame: 3 months follow-up
Inhibition is one of the sub-categories of executive function
13 secondary outcomes
Cognitive function measured by Montreal Cognitive Assessment
Time frame: immediate post-test
Cognitive function measured by Cognitive Change Index(C-CCI)
Time frame: immediate post-test
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Time frame: 3 months follow-up
Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
Time frame: 3 months follow-up
EEG
Time frame: immediate post-test
Change from Baseline EEG at 3 months
Time frame: 3 months follow-up
Visual awareness measured by CANTAB
Time frame: immediate post-test
Visual awareness measured by trail making test
Time frame: immediate post-test
Change from Baseline visual awareness by CANTAB at 3 months
Time frame: 3 months follow-up
Change from Baseline visual awareness by trail making test at 3 months
Time frame: 3 months follow-up
simulator sickness
Time frame: immediate post-test
Usability
Time frame: immediate post-test
Acceptance
Time frame: immediate post-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huei-Ling Chiu principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior Driving Simulation Training in people with MCI and Subjective Cognitive Decline, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental set shifting, measured by Wisconsin Card Sorting Test (time frame: immediate post-test). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.