Cognitive DysfunctionRTCSSCNCT06155721
Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme
A study testing Virtual Reality Cognitive Stimulation Program in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Badalona Serveis Assistencials at 1 site in Spain.
Trial summary
The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Dysfunction, Mild Cognitive Impairment
- What is being tested?
- Virtual Reality Cognitive Stimulation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2023to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than 23.
- Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC).
- Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative.
Who cannot join
- Patients with a severe or unstable illness that could interfere with participation in the study.
- Patients with serious psychiatric disorders, such as psychotic disorders, delusions, or hallucinations that may be exacerbated by the use of virtual reality.
- Patients with severe visual limitations that would prevent the use of virtual reality.
- Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses.
- Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids.
- High sensitivity to motion sickness.
Show all 10Show fewer
- Subjects with epilepsy.
- Patients who are unable or unwilling to give informed consent.
- Withdrawal Criteria
- The emergence of health problems that could interfere with the continuity of participation in the study, or the withdrawal of consent by the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)
The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli.
The main questions it aims to answer are:
Read more
- Will patients with mild cognitive impairment find the VR program enjoyable and easy to use?
- Can VR interventions help improve patients' cognitive functions, specifically attention and memory?
- Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice?
Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will:
- Engage with a VR-based cognitive stimulation program.
- Undergo assessments of the participants´ cognitive functions before and after the intervention.
- Provide feedback on the participants´ experience with the VR program.
Researchers will analyze the data to see if:
- The VR program leads to noticeable improvements in the cognitive abilities of participants.
- The program is well-received and deemed beneficial by both patients and healthcare professionals.
Read the detailed description
Background:
Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes.
Study Design:
This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience.
Objectives:
Primary Objective: To assess the acceptability of the VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment.
Secondary Objectives:
To evaluate whether the VR interventions are perceived as engaging and motivating by the patients, which would suggest positive adherence to the cognitive stimulation program.
To measure changes in cognitive performance, particularly in attention and memory, pre- and post-intervention, to determine the effectiveness of the program.
To understand healthcare professionals' perceptions of the applicability of VR interventions in clinical practice for cognitive stimulation.
To identify potential improvements for the implementation of the VR program based on patient and healthcare staff feedback.
To gather data that could be useful for the development of future VR experiences aimed at patients with cognitive impairments.
Methodology:
Participants will be recruited from the Centro Sociosanitario El Carme and will undergo an initial assessment to establish a cognitive baseline. The participants will then engage in a series of VR sessions designed to provide cognitive stimulation. The program will focus on exercises to enhance attention and memory, incorporating interactive elements to maintain engagement. After completing the sessions, participants will be re-assessed using the same cognitive scales.
Feedback on the VR experience will be collected through structured interviews and questionnaires to gauge acceptability, perceived usefulness, and motivation. Healthcare professionals involved in the administration of the VR program will also be interviewed to understand their views on the integration of VR into therapeutic practices.
Expected Outcomes:
It is hypothesized that the VR program will be well-received by patients, evidenced by high rates of program completion and positive subjective feedback. Post-intervention improvements in cognitive scale scores are expected, indicating the potential efficacy of VR-based stimulation. Insights from healthcare professionals are anticipated to highlight the practicality of VR in clinical settings and suggest improvements for future applications.
Relevance:
The findings from this trial could support the adoption of VR technologies in cognitive rehabilitation, offering a novel, scalable, and potentially more effective approach to managing cognitive impairments. The study may also contribute to the evidence base required for integrating technological innovations into standard healthcare practice.
Conclusion:
By exploring the intersection of VR technology and cognitive rehabilitation, this study seeks to advance the understanding of innovative treatments for cognitive impairments and foster improved patient outcomes through enhanced engagement and stimulation.
- Conditions
- Cognitive Dysfunction, Mild Cognitive Impairment
- Being tested
- Virtual Reality Cognitive Stimulation Program
- Keywords
- Cognitive Stimulation, Virtual Reality, Mild Cognitive Impairment, Cognitive Rehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Cognitive Stimulation ProgramDevice
Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Experimental | Participants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists.
The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). Receives: Device: Virtual Reality Cognitive Stimulation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
Adapted 8-Item System Usability Scale (SUS):
Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability.
Measured: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
Comfort of VR Headset as Measured by an 8-Item SUS:
Adapted 8-Item VR Headset Comfort Rating:
Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort).
Measured: immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary outcomes (9)
Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:
Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate a professional's perception of better system usability for patient care.
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS:
Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate better comfort and ease of use for the VR headset; lower scores indicate greater discomfort and difficulty with use. This rating is based on a professional assessment of the VR headset's weight, design, and control scheme's impact on patient comfort during use.
Measured: immediately post-intervention, within 30 minutes after the 8th session (day 8)
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
MMSE is a 30-point questionnaire evaluating orientation, attention, recall, language, and visual construction Score Range: 0 to 30 points. Higher scores means better global cognition function
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
MoCA is a 30-point screening tool for global cognitive function, assessing memory, attention, language, visuospatial skills, and executive function.
Score Range: 0 to 30 points
- Higher scores means better global cognition function
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Short-Term Memory as Measured by the Digit Span Test (DST Forward Span)
Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points
- Higher scores indicate better short-term verbal memory.
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Working Memory as Measured by the Digit Span Test (DST Backward Span)
Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
TMT-A measures visual attention and processing speed. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes.
Lower times (faster completion) indicate better visuospatial attention.
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
TMTB: Trial Making Test B. Score Range: Time to complete the test measured in seconds, typically ranging from several seconds to several minutes.
Lower times (faster completion) indicate better alternating attention.
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
SDMT: Symbol Digit Modalities Test. The Symbol Digit Modalities Test (SDMT) measures processing speed, attention, and visual-motor coordination. During the test, participants are required to match abstract symbols with corresponding numbers using a key. The total raw score is calculated as the number of correct symbol-digit pairs completed within a 90-second interval. There is no fixed maximum score, as it varies based on individual performance.
Higher scores indicate better processing speed and cognitive performance.
Measured: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start30 Oct 2023
- Primary completion27 Feb 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm interventional study where all participants receive the same intervention- a cognitive stimulation program administered through virtual reality (VR). Participants with mild to moderate cognitive impairment will engage in structured VR sessions aimed at stimulating cognitive functions, particularly attention and memory. The study will monitor participants' cognitive performance through standardized cognitive scales pre- and post-intervention, as well as gather subjective feedback on their experience to evaluate acceptability and motivation. Additionally, healthcare professionals' perceptions of the VR intervention's applicability to clinical practice will be assessed through structured interviews or questionnaires.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badalona Serveis Assistencials
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Barcelona, Reality Telling SL
- Responsible party
- Principal investigator, Jose Ferrer Costa, Badalona Serveis Assistencials
- Investigators
- Jose Ferrer Costa, MD, Principal investigator, Medical Researcher and Project Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155721
- Sponsor's protocol ID
- PI-23-195
- Acronym
- RTCSSC
- Status last verified
- May 2026
- First submitted
- 3 Nov 2023
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable; individual participant data will not be shared.
Publications
Ferrer Costa J, Ciudad MJ, Gonzalez Abad M, Rodriguez Garcia JL. Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment. J Med Ext Real. 2025 Mar 21;2(1):30-42. doi: 10.1089/jmedxr.2024.0051. eCollection 2025.
PubMed 42558145Perra A, Riccardo CL, De Lorenzo V, De Marco E, Di Natale L, Kurotschka PK, Preti A, Carta MG. Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies. Int J Environ Res Public Health. 2023 Jan 14;20(2):1527. doi: 10.3390/ijerph20021527.
PubMed 36674283Zuschnegg J, Schoberer D, Haussl A, Herzog SA, Russegger S, Ploder K, Fellner M, Hofmarcher-Holzhacker MM, Roller-Wirnsberger R, Paletta L, Koini M, Schussler S. Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. BMC Geriatr. 2023 Apr 12;23(1):229. doi: 10.1186/s12877-023-03941-y.
PubMed 37041494Bauer ACM, Andringa G. The Potential of Immersive Virtual Reality for Cognitive Training in Elderly. Gerontology. 2020;66(6):614-623. doi: 10.1159/000509830. Epub 2020 Sep 9.
PubMed 32906122Liao YY, Chen IH, Lin YJ, Chen Y, Hsu WC. Effects of Virtual Reality-Based Physical and Cognitive Training on Executive Function and Dual-Task Gait Performance in Older Adults With Mild Cognitive Impairment: A Randomized Control Trial. Front Aging Neurosci. 2019 Jul 16;11:162. doi: 10.3389/fnagi.2019.00162. eCollection 2019.
PubMed 31379553Gomez-Caceres B, Cano-Lopez I, Alino M, Puig-Perez S. Effectiveness of virtual reality-based neuropsychological interventions in improving cognitive functioning in patients with mild cognitive impairment: A systematic review and meta-analysis. Clin Neuropsychol. 2023 Oct;37(7):1337-1370. doi: 10.1080/13854046.2022.2148283. Epub 2022 Nov 23.
PubMed 36416175Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. Immersive Virtual Reality Exergames for Persons Living With Dementia: User-Centered Design Study as a Multistakeholder Team During the COVID-19 Pandemic. JMIR Serious Games. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987.
PubMed 35044320Papaioannou T, Voinescu A, Petrini K, Stanton Fraser D. Efficacy and Moderators of Virtual Reality for Cognitive Training in People with Dementia and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2022;88(4):1341-1370. doi: 10.3233/JAD-210672.
PubMed 35811514Qiu R, Gu Y, Xie C, Wang Y, Sheng Y, Zhu J, Yue Y, Cao J. Virtual reality-based targeted cognitive training program for Chinese older adults: A feasibility study. Geriatr Nurs. 2022 Sep-Oct;47:35-41. doi: 10.1016/j.gerinurse.2022.06.007. Epub 2022 Jul 12.
PubMed 35839753
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)
- ClinicalTrials.gov ID
- NCT06155721
- Acronym / sponsor ID
- RTCSSC / PI-23-195
- Conditions
- Cognitive Dysfunction, Mild Cognitive Impairment
- Keywords
- Cognitive Stimulation, Virtual Reality, Mild Cognitive Impairment, Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Badalona Serveis AssistencialsUniversity, hospital or other
- Collaborators
- Public Health Agency of Barcelona, Reality Telling SL
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli.
The main questions it aims to answer are:
- Will patients with mild cognitive impairment find the VR program enjoyable and easy to use?
- Can VR interventions help improve patients' cognitive functions, specifically attention and memory?
- Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice?
Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will:
- Engage with a VR-based cognitive stimulation program.
- Undergo assessments of the participants´ cognitive functions before and after the intervention.
- Provide feedback on the participants´ experience with the VR program.
Researchers will analyze the data to see if:
- The VR program leads to noticeable improvements in the cognitive abilities of participants.
- The program is well-received and deemed beneficial by both patients and healthcare professionals.
Detailed description
Background:
Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes.
Study Design:
This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience.
Objectives:
Primary Objective: To assess the acceptability of the VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment.
Secondary Objectives:
To evaluate whether the VR interventions are perceived as engaging and motivating by the patients, which would suggest positive adherence to the cognitive stimulation program.
To measure changes in cognitive performance, particularly in attention and memory, pre- and post-intervention, to determine the effectiveness of the program.
To understand healthcare professionals' perceptions of the applicability of VR interventions in clinical practice for cognitive stimulation.
To identify potential improvements for the implementation of the VR program based on patient and healthcare staff feedback.
To gather data that could be useful for the development of future VR experiences aimed at patients with cognitive impairments.
Methodology:
Participants will be recruited from the Centro Sociosanitario El Carme and will undergo an initial assessment to establish a cognitive baseline. The participants will then engage in a series of VR sessions designed to provide cognitive stimulation. The program will focus on exercises to enhance attention and memory, incorporating interactive elements to maintain engagement. After completing the sessions, participants will be re-assessed using the same cognitive scales.
Feedback on the VR experience will be collected through structured interviews and questionnaires to gauge acceptability, perceived usefulness, and motivation. Healthcare professionals involved in the administration of the VR program will also be interviewed to understand their views on the integration of VR into therapeutic practices.
Expected Outcomes:
It is hypothesized that the VR program will be well-received by patients, evidenced by high rates of program completion and positive subjective feedback. Post-intervention improvements in cognitive scale scores are expected, indicating the potential efficacy of VR-based stimulation. Insights from healthcare professionals are anticipated to highlight the practicality of VR in clinical settings and suggest improvements for future applications.
Relevance:
The findings from this trial could support the adoption of VR technologies in cognitive rehabilitation, offering a novel, scalable, and potentially more effective approach to managing cognitive impairments. The study may also contribute to the evidence base required for integrating technological innovations into standard healthcare practice.
Conclusion:
By exploring the intersection of VR technology and cognitive rehabilitation, this study seeks to advance the understanding of innovative treatments for cognitive impairments and foster improved patient outcomes through enhanced engagement and stimulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm interventional study where all participants receive the same intervention- a cognitive stimulation program administered through virtual reality (VR). Participants with mild to moderate cognitive impairment will engage in structured VR sessions aimed at stimulating cognitive functions, particularly attention and memory. The study will monitor participants' cognitive performance through standardized cognitive scales pre- and post-intervention, as well as gather subjective feedback on their experience to evaluate acceptability and motivation. Additionally, healthcare professionals' perceptions of the VR intervention's applicability to clinical practice will be assessed through structured interviews or questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Cognitive Stimulation Program | Experimental | Device: Virtual Reality Cognitive Stimulation ProgramParticipants with MCI undergo 8 VR sessions, using Oculus Quest 2 headsets for immersive cognitive exercises. Activities include a Supermarket Shopping Task for memory, a Payment Task for cognitive flexibility, and a Recipe Sequencing Task for problem-solving. Additionally, 360-degree videos with visuo-verbal stimulation are used to engage attention and episodic memory, monitored by therapists. The investigators employ Oculus Quest 2 VR headsets with hand tracking technology to provide a seamless and immersive experience, especially beneficial for participants with Mild Cognitive Impairment (MCI). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than 23.
- Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC).
- Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative.
Key exclusion criteria (10 listed)
- Patients with a severe or unstable illness that could interfere with participation in the study.
- Patients with serious psychiatric disorders, such as psychotic disorders, delusions, or hallucinations that may be exacerbated by the use of virtual reality.
- Patients with severe visual limitations that would prevent the use of virtual reality.
- Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses.
- Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Cognitive Stimulation ProgramIntervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training. | Device | Virtual Reality Cognitive Stimulation Program |
Primary outcome
Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS)
Time frame: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability.
Comfort of VR Headset as Measured by an 8-Item SUS:
Time frame: immediately post-intervention, within 30 minutes after the 8th session (day 8)
Adapted 8-Item VR Headset Comfort Rating: Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort).
9 secondary outcomes
Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS:
Time frame: immediately post-intervention, within 30 minutes after the 8th session (day 8)
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Short-Term Memory as Measured by the Digit Span Test (DST Forward Span)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Working Memory as Measured by the Digit Span Test (DST Backward Span)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
Time frame: Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 42558145Ferrer Costa J, Ciudad MJ, Gonzalez Abad M, Rodriguez Garcia JL. Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment. J Med Ext Real. 2025 Mar 21;2(1):30-42. doi: 10.1089/jmedxr.2024.0051. eCollection 2025.
- Background: PubMed 36674283Perra A, Riccardo CL, De Lorenzo V, De Marco E, Di Natale L, Kurotschka PK, Preti A, Carta MG. Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies. Int J Environ Res Public Health. 2023 Jan 14;20(2):1527. doi: 10.3390/ijerph20021527.
- Background: PubMed 37041494Zuschnegg J, Schoberer D, Haussl A, Herzog SA, Russegger S, Ploder K, Fellner M, Hofmarcher-Holzhacker MM, Roller-Wirnsberger R, Paletta L, Koini M, Schussler S. Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. BMC Geriatr. 2023 Apr 12;23(1):229. doi: 10.1186/s12877-023-03941-y.
- Background: PubMed 32906122Bauer ACM, Andringa G. The Potential of Immersive Virtual Reality for Cognitive Training in Elderly. Gerontology. 2020;66(6):614-623. doi: 10.1159/000509830. Epub 2020 Sep 9.
- Background: PubMed 31379553Liao YY, Chen IH, Lin YJ, Chen Y, Hsu WC. Effects of Virtual Reality-Based Physical and Cognitive Training on Executive Function and Dual-Task Gait Performance in Older Adults With Mild Cognitive Impairment: A Randomized Control Trial. Front Aging Neurosci. 2019 Jul 16;11:162. doi: 10.3389/fnagi.2019.00162. eCollection 2019.
- Background: PubMed 36416175Gomez-Caceres B, Cano-Lopez I, Alino M, Puig-Perez S. Effectiveness of virtual reality-based neuropsychological interventions in improving cognitive functioning in patients with mild cognitive impairment: A systematic review and meta-analysis. Clin Neuropsychol. 2023 Oct;37(7):1337-1370. doi: 10.1080/13854046.2022.2148283. Epub 2022 Nov 23.
- Background: PubMed 35044320Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. Immersive Virtual Reality Exergames for Persons Living With Dementia: User-Centered Design Study as a Multistakeholder Team During the COVID-19 Pandemic. JMIR Serious Games. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987.
- Background: PubMed 35811514Papaioannou T, Voinescu A, Petrini K, Stanton Fraser D. Efficacy and Moderators of Virtual Reality for Cognitive Training in People with Dementia and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2022;88(4):1341-1370. doi: 10.3233/JAD-210672.
- Background: PubMed 35839753Qiu R, Gu Y, Xie C, Wang Y, Sheng Y, Zhu J, Yue Y, Cao J. Virtual reality-based targeted cognitive training program for Chinese older adults: A feasibility study. Geriatr Nurs. 2022 Sep-Oct;47:35-41. doi: 10.1016/j.gerinurse.2022.06.007. Epub 2022 Jul 12.
- Organización Mundial de la Salud. (2023). Demencia, 15 de marzo de 2023. Datos y cifras.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable; individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Ferrer Costa, MD principal investigator
Medical Researcher and Project Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Cognitive Stimulation Program in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Badalona Serveis Assistencials at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) (time frame: immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155721, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.