Virtual Reality Cognitive Stimulation for Alzheimer's (CODDI)

Cognitive Stimulation and Memory Enhancement Through Virtual Reality in Patients With Alzheimer's Disease: A Behavioral, Biometric, and Neurocognitive Assessment

This study aims to evaluate whether immersive virtual reality (VR) can improve cognitive function and memory in patients with Alzheimer's disease. Twenty participants in Burgos, Spain, will engage in VR sessions that recreate scenes from 1960s Burgos, representing environments familiar from the participants' youth. The effects of these VR-based cognitive stimulation sessions will be assessed through pre- and post-intervention evaluations, including behavioral observations, EEG monitoring of brain activity, and standardized neurocognitive tests (Montreal Cognitive Assessment, Clock-Drawing Test, and Verbal Fluency Test).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Memory Disorders
• Intervention / Treatment: Other: Virtual reality

Detailed Description

Introduction: Alzheimer's disease is a neurodegenerative condition characterized by progressive cognitive decline. Virtual reality (VR) technologies offer an innovative approach to cognitive stimulation in patients with this condition. This study will evaluate the impact of VR on memory and cognition improvement in patients with Alzheimer's disease in Burgos.

Objective: Evaluate the effectiveness of cognitive and memory stimulation through virtual reality experiences in patients with Alzheimer's disease, using behavioral analysis, biometric data (EEG), and neurocognitive testing.

Methodology: A total of 20 patients diagnosed with Alzheimer's disease at a specialized center in Burgos will be selected. The patients will be exposed to virtual reality scenarios recreating the city of Burgos in the 1960s, a period corresponding to their youth. Their cognitive and emotional status will be assessed before and after the sessions using neurocognitive tests, behavioral monitoring, and biometric data recording (EEG). Analyses of variance (ANOVA), analyses of covariance (ANCOVA), and multivariate analyses of variance (MANOVA) were perfomed

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Burgos
    • Burgos, Burgos, Spain, 09001
      • University of Burgos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosed with mild cognitive impairment
• Aged 60 years or older.
• Resident or attending care at the Alzheimer's care center in Burgos.
• Capable of providing informed consent, either directly or through a legally authorized representative.
• Adequate vision and hearing (corrected if necessary) to engage with the VR experience.
• Able to tolerate wearing a VR headset for sessions of approximately 15-30 minutes.

Exclusion Criteria:

• Diagnosis of other neurodegenerative disorders (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis).
• History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
• Severe vision or hearing impairment that cannot be corrected (e.g., legal blindness).
• History of epilepsy, seizure disorders, or other conditions that may be aggravated by VR exposure.
• Active skin conditions or infections that prevent the use of a VR headset or EEG sensors.
• Participation in another interventional clinical trial within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The sample consisted of 33 people: 16 in the experimental group.	Other: Virtual reality; The intervention consists of a series of immersive virtual reality (VR) sessions designed to provide cognitive stimulation for patients diagnosed with Alzheimer's disease. Participants in the experimental group will be exposed to VR environments that recreate the city of Burgos as it appeared in the 1960s, an era corresponding to their youth. These VR experiences will include familiar scenes, landmarks, and culturally relevant settings designed to evoke personal memories and enhance cognitive engagement.
No Intervention: Control group; The sample consisted of 33 people: 17 in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Function (Montreal Cognitive Assessment - MoCA)	Change in cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates multiple cognitive domains, including memory, attention, language, executive function, and visuospatial abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive function. The change score will be calculated as the post-intervention score minus the baseline score.	Baseline and immediately after the last virtual reality session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional well-being assessed with the Satisfaction With Life Scale (SWLS)	Change in emotional well-being will be assessed using the Satisfaction With Life Scale (SWLS). The SWLS is a 5-item scale that assesses global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life and better emotional well-being. The change score will be calculated as the post-intervention score minus the baseline score.	Baseline and immediately after the last virtual reality session
Change in Verbal Fluency (Verbal Fluency Test)	Change in the number of words generated in a 60-second period, assessing language and cognitive processing speed.	Baseline and post-intervention.
Change in attention and processing speed	Attention, visual scanning, and processing speed will be assessed using the Trail Making Test Part A. The outcome will be the time required to complete the task. Lower completion times indicate better performance.	Baseline and immediately after the last virtual reality session
Change in executive function and cognitive flexibility assessed with the Trail Making Test Part B (TMT-B)	Executive function and cognitive flexibility will be assessed using the Trail Making Test Part B. The outcome will be the time required to complete the task. Lower completion times indicate better performance.	Baseline and immediately after the last virtual reality session
Change in positive affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)	Positive affect will be assessed using the positive affect subscale of the Positive and Negative Affect Schedule Short Form (PANAS-S). Higher scores indicate greater positive affect.	Baseline and immediately after the last virtual reality session.
Change in negative affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)	Negative affect will be assessed using the negative affect subscale of the Positive and Negative Affect Schedule Short Form (PANAS-S). Higher scores indicate greater negative affect.	Baseline and immediately after the last virtual reality session
Immediate emotional response assessed with an Emotional Visual Analog Scale	Immediate emotional response will be assessed after each intervention session using an Emotional Visual Analog Scale ranging from 0 to 10, where higher scores indicate a more positive emotional state.	Baseline and immediately after the last virtual reality session

Collaborators and Investigators

• Sponsor: Universidad de Burgos

Publications and helpful links

General Publications

• Maggio MG, Latella D, Maresca G, Sciarrone F, Manuli A, Naro A, De Luca R, Calabro RS. Virtual Reality and Cognitive Rehabilitation in People With Stroke: An Overview. J Neurosci Nurs. 2019 Apr;51(2):101-105. doi: 10.1097/JNN.0000000000000423.
• Redmond LW. Spiritual coping tools of religious victims of childhood sexual abuse. J Pastoral Care Counsel. 2014 Mar-Jun;68(1-2):3.
• Zhang J, Wu M, Li J, Song W, Lin X, Zhu L. Effects of virtual reality-based rehabilitation on cognitive function and mood in multiple sclerosis: A systematic review and meta-analysis of randomized controlled trials. Mult Scler Relat Disord. 2024 Jul;87:105643. doi: 10.1016/j.msard.2024.105643. Epub 2024 May 9.
• Garcia-Betances RI, Jimenez-Mixco V, Arredondo MT, Cabrera-Umpierrez MF. Using virtual reality for cognitive training of the elderly. Am J Alzheimers Dis Other Demen. 2015 Feb;30(1):49-54. doi: 10.1177/1533317514545866. Epub 2014 Aug 7.
• Wang Z, Cao Y, Zhang K, Guo Z, Liu Y, Zhou P, Liu Z, Lu X. Gold nanoparticles alleviates the lipopolysaccharide-induced intestinal epithelial barrier dysfunction. Bioengineered. 2021 Dec;12(1):6472-6483. doi: 10.1080/21655979.2021.1972782.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: virtual reality; cognitive therapy; alzheimer disease; neuropsychological tests
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Alzheimer Disease; Memory Disorders
• Other Study ID Numbers: CODDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No