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

Healthy Aging Clinical Trial

— SDST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380284
• Other study ID #: N202002083
• Status: Completed
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: May 28, 2023

Study information

• Verified date: May 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 28, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy Aging
• MCI
• Subjective Cognitive Decline

Intervention

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) .
• Waiting list control
The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental set shifting, measured by Wisconsin Card Sorting Test	Mental set shifting is one of the sub-categories of executive function	immediate post-test
Primary	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
Primary	Working memory, measured by Digit span test	Working memory is one of the sub-categories of executive function	immediate post-test
Primary	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
Primary	Inhibition, measured by the Stroop Color and Word Test	Inhibition is one of the sub-categories of executive function	immediate post-test
Primary	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	Cognitive function measured by Montreal Cognitive Assessment	Cognitive function measured by Montreal Cognitive Assessment	immediate post-test
Secondary	Cognitive function measured by Cognitive Change Index(C-CCI)	Cognitive function measured by Cognitive Change Index(C-CCI)	immediate post-test
Secondary	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
Secondary	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
Secondary	EEG	EEG power in delta, theta, alpha, and beta band	immediate post-test
Secondary	Change from Baseline EEG at 3 months	EEG power in delta, theta, alpha, and beta band	3 months follow-up
Secondary	Visual awareness measured by CANTAB	Visual awareness measured by CANTAB	immediate post-test
Secondary	Visual awareness measured by trail making test	Visual awareness measured by trail making test	immediate post-test
Secondary	Change from Baseline visual awareness by CANTAB at 3 months	Visual awareness measured by CANTAB	3 months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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