NCT05380284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 30, 2022

Last Update Submit

May 29, 2023

Conditions

MCISubjective Cognitive DeclineHealthy Aging

Keywords

driving simulationexecutive functionbrain wave

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (13)

  • Cognitive function measured by Montreal Cognitive Assessment

    immediate post-test

  • Cognitive function measured by Cognitive Change Index(C-CCI)

    immediate post-test

  • 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

    3 months follow-up

  • EEG

    immediate post-test

  • +8 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

Senior Driving Simulation Training

Other: Senior Driving Simulation Training

Control Group

OTHER

Ｗaiting-list

Other: Waiting list control

Interventions

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) .

Experimental Group
Waiting list controlOTHER

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

Control Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Dementia, diagnosed by a physician and in compliance with ICD-10.
  • Significant mental illness or communication impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Study Officials

  • Huei-Ling Chiu

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 18, 2022

Study Start

June 28, 2022

Primary Completion

January 1, 2023

Study Completion

May 28, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)