Full‑immersive virtual reality cognitive training for people with mild to moderate dementia
The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia
This project will try a fully immersive virtual reality leisure cognitive training program for people over 55 with mild to moderate dementia to see if it helps thinking, daily activities, and mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT07033468 on ClinicalTrials.gov |
What this trial studies
The project begins with a feasibility phase in which 10 participants will complete a single VR session and have feasibility and emotion-related measures recorded before and after. The efficacy phase is a randomized crossover trial planning to enroll about 30 participants to receive 15 training sessions, each 65 minutes long, delivered three times per week. Outcomes include a primary cognitive function measure and secondary outcomes such as activities of daily living, quality of life, emotion, and clinical symptoms. Within-subject comparisons across the crossover will be used to determine whether the VR leisure cognitive training produces measurable benefits.
Who should consider this trial
Good fit: Ideal candidates are people aged over 55 with physician-diagnosed mild to moderate (degenerative) dementia, MMSE scores between 11 and 23, able to walk independently, able to follow instructions (with help if needed), and who have at least one regular family contact or caregiver.
Not a fit: Patients with dementia caused by specific disorders such as Lewy body dementia or other nondegenerative causes, those with severe dementia or who cannot provide informed consent or tolerate VR, and those with major sensory or mobility limitations are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the VR program could improve cognition, daily functioning, and emotional well-being while offering an engaging, nonpharmacologic therapy option.
How similar studies have performed: Early pilot and small randomized studies of immersive and nonimmersive VR in dementia have shown promising effects on engagement, mood, and some cognitive measures, but larger high-quality randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Taipei City
- Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundation. — New Taipei City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ching-yi Wu, ScD — Chang Gung Memorial Hospital
- Study coordinator: Ching-yi Wu, ScD
- Email: cywu@mail.cgu.edu.tw
- Phone: #886-3-2118800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.