Virtual Reality Cognitive Stimulation for Alzheimer's

NCT07645638 | Completed

• 1 other identifier: CODDI
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alzheimer Disease; Memory Disorders

Keywords

alzheimer disease; virtual reality; cognitive therapy; neuropsychological tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in emotional well-being assessed with the Satisfaction With Life Scale (SWLS)

  Baseline and immediately after the last virtual reality session

• Change in Verbal Fluency (Verbal Fluency Test)

  Baseline and post-intervention.

• Change in attention and processing speed

  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)

  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)

  Baseline and immediately after the last virtual reality session.

Study Arms (2)

Experimental group

EXPERIMENTAL

The sample consisted of 33 people: 16 in the experimental group.

Other: Virtual reality

Control group

NO INTERVENTION

The sample consisted of 33 people: 17 in the control group.

Interventions

Virtual reality OTHER

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.

Experimental group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

University of Burgos

Burgos, Burgos, 09001, Spain

Location

Related Publications (5)

• Redmond LW. Spiritual coping tools of religious victims of childhood sexual abuse. J Pastoral Care Counsel. 2014 Mar-Jun;68(1-2):3.

  PMID: 25241481 BACKGROUND

• 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.

  PMID: 30649091 BACKGROUND

• 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.

  PMID: 38735202 BACKGROUND

• 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.

  PMID: 25107931 BACKGROUND

• 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.

  PMID: 34523392 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Memory Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a experimental design with non-equivalent groups (pretest-posttest) carried out in a more realistic setting, where the dependent variables of interest were manipulated by the researcher under controlled conditions.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 12, 2026
• Study Start: January 8, 2025
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)