The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia

NCT07033468 | Recruiting

• 1 other identifier: 202400517B0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. The feasibility study will assess the feasibility and emotion-related indicators of 10 patients before and after a single training session. The efficacy study is planned to adopt a crossover randomized controlled trial, recruiting 30 patients for 15 sessions, each lasting 65 minutes, conducted three times a week. The assessment will include tests on the primary variable of cognitive function and secondary variables such as activities of daily living, quality of life, emotion, clinical symptoms, etc.

Conditions

Mild to Moderate Dementia

Outcome Measures

Primary Outcomes (4)

• Change scores of Montreal Cognitive Assessment

  The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. Minimum: 0 (worst performance) Maximum: 30 (best performance) The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of Stroop test

  The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition.Minimum: 0 , Maximum: but typically no upper limit. Higher scores indicate worse performance (greater cognitive interference and slower response time).

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of Color trials test

  For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.Minimum: Greater than 1 second (best performance) Maximum: No upper limit .Higher scores indicate worse performance (longer completion time and greater cognitive impairment).

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of Frontal Assessment Battery

  This study utilizes this scale to assess various aspects of frontal lobe function, including executive function, behavioral regulation, and planning. The test consists of six subtests: Similarities, Verbal Fluency, Motor Sequencing, Conflicting Instructions, Go-No-Go, and Comprehending Behavior. Each subtest is scored from 0 to 3, with a total possible score of 18 points. The Taiwanese version of the frontal assessment scale has demonstrated good reliability and validity, showing consistency with tconsistency with the original version and strong construct validity. Minimum: 0 (worst performance) Maximum: 18 (best performance) Higher scores indicate better frontal lobe function, while lower scores suggest greater impairment.

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

Secondary Outcomes (6)

• Change scores of Barthel Index

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of The Chinese Dementia-Quality of Life instrument, DQoL

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of The Cornell Scale for Depression in Dementia Chinese version

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

• Change scores of Clinical Dementia Rating, CDR

  Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .

Study Arms (2)

VR training therapy

EXPERIMENTAL

Guide the patient through a 5-minute warm-up, which mainly involves explaining, familiarizing with, or reviewing VR operations. After the warm-up, proceed with the first part of the VR gardening training for 10 minutes, followed by 5 minutes of eye and stretching exercises. Then, continue with the second part of the VR gardening training for another 10 minutes, followed by 5 minutes of eye massage and stretching exercises. This sequence is repeated for a total of four cycles.

Device: VR-WLC; Device: CTL-VR

Waitlist control session

OTHER

During the waitlist period, patients will not receive any training but will receive regular phone calls to ensure equal attention.

Device: VR-WLC; Device: CTL-VR

Interventions

VR-WLC DEVICE

First, conduct the Virtual Reality (VR) training activity. After the evaluation is completed, proceed to the Waitlist Control (WLC) session, approximately 5 to 10 weeks later.

VR training therapy; Waitlist control session

CTL-VR DEVICE

First, conduct the Control (CTL) session for approximately 5 to 10 weeks. After the evaluation is completed, proceed to the Virtual Reality (VR) training activity.

VR training therapy; Waitlist control session

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 55 years;
• Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
• A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
• Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
• Able to walk independently and complete the Timed Up \& Go (TUG) test;
• Able to follow instructions with or without the assistance of a guardian or therapist;
• If the assessment indicates moderate dementia, further evaluation will be conducted to determine whether the participant has sufficient capacity to provide informed consent. If their capacity is found to be impaired, the study will be explained to their legal representative

You may not qualify if:

• Dementia with Lewy Bodies and other dementia types resulting from specific causes, such as Huntington's Disease, substance addiction, central nervous system infections, nutritional deficiencies, and metabolic disorders.
• Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
• A psychiatric diagnosis of psychosis within the past six months.
• Diagnosis of Korsakoff syndrome.
• History of substance addiction.
• Severe hearing impairment or color blindness.
• History of severe vertigo or epilepsy.
• Concurrent participation in other studies that may affect cognitive function

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundation.

New Taipei City, Taiwan

RECRUITING

Study Officials

• Ching-yi Wu, ScD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-yi Wu, ScD

CONTACT

#886-3-2118800; cywu@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-02

Locations

TW (1)