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Completed

NCT Number: NCT06977815

Non-randomized Clinical Trial on Cognitive Stimulation With Virtual Reality in Patients With Mild Cognitive Impairment

The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. One group will also use immersive VR for 15-20 minutes at the end of each session. Participants will attend 2 sessions per week, completing at least 20 sessions and up to 22, depending on the clinic's schedule. Researchers will measure changes in attention, memory, and thinking skills using standard cognitive tests. They will also collect feedback on how participants experience the VR exercises.

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Key information

Conditions

Mild Cognitive Impairment Aging Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Socio Sanitario El Carmen

Badalona, Barcelona, 08917, Spain

About this study

This clinical trial evaluates a cognitive rehabilitation program enhanced with virtual reality (VR) for older adults with mild cognitive impairment (MCI). The study investigates whether adding immersive VR exercises to a conventional program improves cognitive performance compared to standard cognitive rehabilitation alone.

All participants take part in a structured, computer-based cognitive training program delivered over 12 weeks. Sessions occur twice per week, with participants completing at least 20 and up to 22 sessions depending on clinic scheduling. The intervention group receives an additional 15-20 minutes of immersive VR content at the end of each session. VR exercises target attention, memory, and executive functioning, aiming to increase engagement and therapeutic value.

This trial complements a previously registered pilot study (ClinicalTrials.gov Identifier: NCT06155721) and builds on its published results.

Cognitive performance will be assessed using standardized neuropsychological tests including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Digit Span, Trail Making Test (TMT), and Symbol Digit Modalities Test (SDMT). Functional capacity will be evaluated using the Lawton-Brody scale. Usability and satisfaction with the VR system will be measured in the intervention group using the System Usability Scale (SUS) and a custom satisfaction questionnaire.

The study was implemented pragmatically within routine clinical care. Allocation followed the pre-existing attendance schedule of the psychogeriatric day hospital. For logistical and ethical reasons related to service implementation, one comparator group was later offered the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. Analyses will distinguish unique participants from rehabilitation episodes to account for this sequential access.

The study has been approved by the Germans Trias i Pujol University Hospital Research Ethics Committee (PI-24-210) and complies with the Declaration of Helsinki and the European General Data Protection Regulation (GDPR).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults aged ≥60 years, classified as having mild cognitive impairment or early cognitive impairment, with MMSE >20, regularly attending cognitive stimulation sessions at the CSSC day hospital and able to provide informed consent or consent through a legal representative.

Exclusion criteria

Severe or unstable illness interfering with participation, severe psychiatric symptoms that could be exacerbated by VR, severe visual or hearing impairment preventing participation, high sensitivity to motion sickness, epilepsy, or inability or unwillingness to provide informed consent.

Treatment and study plan

VR-Enhanced Cognitive Rehabilitation

Behavioral

A program consisting of 45-minute computer-based cognitive rehabilitation exercises, enhanced with 15-20 minutes of immersive virtual reality (VR) content per session. The VR component targets memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks.

Other names: Virtual Reality Cognitive Support

Standard Cognitive Rehabilitation

Behavioral

A program consisting of 45-minute computer-based cognitive rehabilitation exercises targeting memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks. No VR content is included.

Other names: Computer-Based Cognitive Training

Primary outcomes

  1. Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    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

  2. Global Cognition as Measured by the Mini-Mental State Examination (MMSE)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    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

  3. Short-Term Memory as Measured by the Digit Span Test (Forward Span)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points Higher scores reflect better performance.

  4. Working Memory as Measured by the Digit Span Test (Backward Span)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.

  5. Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    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.

  6. Executive Function as Measured by the Trail Making Test Part B (TMT-B)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    TMT-B assesses alternating attention and executive control. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes.

    Lower times (faster completion) indicate better alternating attention.

  7. Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    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.

  8. Functional Capacity as Measured by the Lawton-Brody Instrumental Activities of Daily Living Scale

    Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)

    The Lawton-Brody Instrumental Activities of Daily Living Scale evaluates functional independence in activities such as telephone use, shopping, cooking, and managing finances. Scores range from 0 to 8, with higher scores indicating greater independence. Each task is scored as independent (1) or dependent (0).

Secondary outcomes

  1. Patient Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)

    Time frame: Post-intervention (Week 12, within 1 week after last session)

    Participants rate the comfort and tolerability of the Meta Quest 2 or 3 headset after the final session. The scale includes 8 items addressing physical discomfort (e.g., weight, visual strain, dizziness, fatigue, and headache).

    Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate greater headset tolerability and comfort.

  2. Patient Comfort and Tolerability of the VR Headset as Measured by an 8-Item Adapted Scale

    Time frame: Post-intervention (Week 12, within 1 week after last session)

    Participants rate the comfort and tolerability of the Meta Quest 2 or 3 headset after the final session. The scale includes 8 items addressing physical discomfort (e.g., weight, visual strain, dizziness, fatigue, and headache).

    Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate greater headset tolerability and comfort.

  3. Clinician Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)

    Time frame: Post-intervention (Week 12, within 1 week after last session)

    An adapted SUS completed by professionals delivering the intervention. The 8 items assess perceived usability, integration into clinical workflow, and ease of use for patients.

    Score Range: 0 to 100 Interpretation: Higher scores indicate better usability.

  4. Clinician Perception of VR Headset Comfort for Patients as Measured by a 3-Item Questionnaire

    Time frame: Post-intervention (Week 12, within 1 week after last session)

    Professionals rate their perception of how comfortable and manageable the VR headset is for patients. The 3 items assess concerns such as weight, usability of controls, and prolonged wear tolerance.

    Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate better perceived comfort and usability for patients.

Other outcomes

  1. Participant Age

    Time frame: Baseline

    Age in years, collected at baseline. Used to describe the study population and for subgroup analysis if needed.

  2. Participant Sex

    Time frame: Baseline

    Self-reported biological sex, categorized as:

    0 = Female

    1 = Male 3 = Other Collected at baseline to describe participant characteristics.

Sponsors and collaborators

Lead sponsor

Badalona Serveis Assistencials

Other

Registry information

Official study title

Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve

Acronym: RVEC-DCL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jul 8, 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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