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Completed

NCT Number: NCT07645638

Virtual Reality Cognitive Stimulation for Alzheimer's

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).

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Key information

Conditions

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

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Burgos

Burgos, 09001, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Cognitive Function (Montreal Cognitive Assessment - MoCA)

    Time frame: Baseline and immediately after the last virtual reality session

    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.

Secondary outcomes

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

    Time frame: Baseline and immediately after the last virtual reality session

    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.

  2. Change in Verbal Fluency (Verbal Fluency Test)

    Time frame: Baseline and post-intervention.

    Change in the number of words generated in a 60-second period, assessing language and cognitive processing speed.

  3. Change in attention and processing speed

    Time frame: Baseline and immediately after the last virtual reality session

    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.

  4. Change in executive function and cognitive flexibility assessed with the Trail Making Test Part B (TMT-B)

    Time frame: Baseline and immediately after the last virtual reality session

    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.

  5. Change in positive affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)

    Time frame: Baseline and immediately after the last virtual reality session.

    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.

  6. Change in negative affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)

    Time frame: Baseline and immediately after the last virtual reality session

    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.

  7. Immediate emotional response assessed with an Emotional Visual Analog Scale

    Time frame: Baseline and immediately after the last virtual reality session

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

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

Acronym: CODDI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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