Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06072014
Other study ID # AXEL0003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date December 2023

Study information

Verified date September 2023
Source Augmented eXperience E-health Laboratory
Contact Roland Dominic G. Jamora, MD, PhD
Phone +639985438062
Email rgjamora@up.edu.ph
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Aged 60 years old or older - Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria - Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive - Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive - Reisberg Scale Stage 4-5 inclusive - Stable dose of antidepressants for the past 6 weeks - Stable dose of antipsychotics for the past 4 weeks - Able to walk unassisted or with minimal assistance, with or without assistive device - No other explanation for condition based on reasonable clinical diagnostics Exclusion Criteria: - Have mild cognitive impairment (no dementia) - Have MOCA-P score less than 10 or more than 20 - Other non-amnestic dementia syndromes - Have receptive aphasia - Have significant visual or hearing impairment - Have an active psychiatric disorder prior to Alzheimer dementia diagnosis - Had previous episodes of seizures, diagnosis of epilepsy, or intake of antiepileptic or seizure medications - Have quadriplegia or paralysis of the dominant hand - Have a history of motion sickness - Experience claustrophobia - Have a diagnosis of a terminal illness or a life expectancy of less than one year

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality
A role-playing game with activities based on existing therapy activities (such as orientation therapy, reminiscence therapy, art therapy, and music therapy) that are used to manage behavioral and psychological symptoms of dementia

Locations

Country Name City State
Philippines University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory City Of Manila National Capital Region

Sponsors (1)

Lead Sponsor Collaborator
Augmented eXperience E-health Laboratory

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Anlacan, V.M.M. et al. (2023). Application Design for a Virtual Reality Therapy Game for Patients with Behavioral and Psychological Symptoms of Dementia. In: Krouska, A., Troussas, C., Caro, J. (eds) Novel & Intelligent Digital Systems: Proceedings of the 2nd International Conference (NiDS 2022). NiDS 2022. Lecture Notes in Networks and Systems, vol 556. Springer, Cham. https://doi.org/10.1007/978-3-031-17601-2_15

Outcome

Type Measure Description Time frame Safety issue
Other Acceptability Acceptability will be measured among a small group of patients and their caregivers through an interview and a focus group discussion Within one day after completing virtual reality experience
Primary Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12 The NPI evaluates the degree and severity of BPSDs and the distress it causes the primary caregiver. Scores range from 0 to 120 where higher scores indicate greater psychiatric disturbance. Within one hour after completion of the fourth session
Primary Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe. Immediately after each intervention, within an hour of completion of the virtual reality game
Primary Usability of the virtual reality intervention will be assessed using the System Usability Scale The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average. Immediately after each intervention, within an hour of completion of the virtual reality game
Secondary Cognitive function will be assessed using MOCA-P Montreal Cognitive Assessment-Philippines (MOCA-P) is a 30-item test that takes about 10-12 minutes to complete. The test measures different cognitive domains such as visuospatial/executive, naming, memory, attention, language, abstraction, and orientation. Within one hour after completion of the fourth session
Secondary Cognitive function will be assessed using MMSE The Mini-Mental State Exam (MMSE) is a 30-item test for cognitive function. It assesses attention, orientation, memory, registration, recall, calculation, language, and an individual's ability to draw a complex polygon. Within one hour after completion of the fourth session
Secondary Cognitive function will be assessed using ADAS-Cog The cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) is an 11-item tool for the assessment of the following tasks: word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, and language. Within one hour after completion of the fourth session
Secondary Activities of daily living will be assessed using ADCS-ADL The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) is a 24-item assessment on activities of daily living within the past four weeks Within one hour after completion of the fourth session
Secondary Health-related quality of life will be assessed using DEMQOL The Health-related quality of life for people with dementia (DEMQOL) is a 28-item self-report measure of quality of life specific for persons with mild-to-moderate dementia. It covers four dimensions of quality of life, namely, daily activities, memory, negative emotion, and positive emotion. Within one hour after completion of the fourth session
See also
  Status Clinical Trial Phase
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT03378245 - Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations N/A
Recruiting NCT04871698 - On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs
Active, not recruiting NCT05847153 - MASC: Reducing Stress for Caregivers N/A
Recruiting NCT04863859 - Persons With Dementia and Their Extended Family Caregivers
Active, not recruiting NCT05529277 - Implementing Dementia Care Management Into Routine Care in the Region Siegen-Wittgenstein
Active, not recruiting NCT03631069 - Detecting Dementia in the Retina Using Optical Coherence Tomography
Not yet recruiting NCT06047340 - Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease N/A
Terminated NCT03682874 - Identifying Novel Aging Targets for Treatment of Delirium
Completed NCT03907748 - Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia N/A
Completed NCT04058886 - Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers N/A
Not yet recruiting NCT05606445 - Surface EMG to Measure Paratonia in Dementia
Recruiting NCT04308512 - Care Coordination System for People With Dementia Phase 1/Phase 2
Active, not recruiting NCT03943641 - Dementia Risk Prediction Model: Development and Validation
Not yet recruiting NCT05245903 - Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
Not yet recruiting NCT06396377 - Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder N/A
Recruiting NCT03472482 - Optical Coherence Tomography in Cerebral Amyloidosis
Recruiting NCT04313582 - Feasibility of the SmartPrompt for Improving Everyday Function in Dementia N/A
Recruiting NCT05315895 - The Dampness Syndrome of Chinese Medicine Cohort Study
Completed NCT04462029 - A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers Early Phase 1