Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment (SDST)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging; MCI; Subjective Cognitive Decline
• Intervention / Treatment: Other: Senior Driving Simulation Training; Other: Waiting list control

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Huei-Ling Chiu, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): May 28, 2023

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: May 14, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: executive function; driving simulation; brain wave
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: N202002083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No