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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Mild to Moderate Dementia

Treatments: Device: VR-WLC; Device: CTL-VR

Study type: Interventional

Funder types: Other

Identifiers

NCT07033468

202400517B0

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 55 years;
2. Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
3. A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
4. Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
5. Able to walk independently and complete the Timed Up & Go (TUG) test;
6. Able to follow instructions with or without the assistance of a guardian or therapist;
7. 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

Exclusion criteria

1. 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.
2. Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
3. A psychiatric diagnosis of psychosis within the past six months.
4. Diagnosis of Korsakoff syndrome.
5. History of substance addiction.
6. Severe hearing impairment or color blindness.
7. History of severe vertigo or epilepsy.
8. Concurrent participation in other studies that may affect cognitive function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

VR training therapy

Experimental group

Description:

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.

Treatment:

Device: CTL-VR

Device: VR-WLC

Waitlist control session

Other group

Description:

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

Treatment:

Device: CTL-VR

Device: VR-WLC