Clinical trial NCT06977815: Non-randomized Clinical Trial on Cognitive Stimulation With Virtual Reality in Patients With Mild Cognitive Impairment
Official title: Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Dysfunction
Aging
Keywords: Virtual Reality
Cognitive Rehabilitation
Older Adults
VR-Enhanced Therapy
Neurocognitive Disorders
Cognitive Stimulation
Gerontology
Lead sponsor: Badalona Serveis Assistencials
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: one receiving computer-based cognitive rehabilitation with added virtual reality (VR); the other receiving computer-based cognitive rehabilitation only.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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 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).

Eligibility criteria: Inclusion Criteria:

* Age between 60 or older
* Clinical diagnosis of mild cognitive impairment (MCI)
* Preserved autonomy in basic and instrumental activities of daily living
* MoCA score between 18 and 26
* Ability to use a computer interface with or without assistance
* Capacity to understand and sign informed consent

Exclusion Criteria:

* Diagnosis of dementia (MMSE \< 18 or clinical judgment)
* Severe visual or hearing impairment affecting task participation
* History of epilepsy, vertigo, or conditions contraindicating VR use
* Severe psychiatric or neurological illness (e.g., major depression, Parkinson's disease)
* Enrollment in other cognitive training programs during the study period

Primary outcomes:
measure: Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Short-Term Memory as Measured by the Digit Span Test (Forward Span)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Working Memory as Measured by the Digit Span Test (Backward Span)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Executive Function as Measured by the Trail Making Test Part B (TMT-B)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
measure: Functional Capacity as Measured by the Lawton-Brody Instrumental Activities of Daily Living Scale
timeFrame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Secondary outcomes:
measure: Patient Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
timeFrame: Post-intervention (Week 12, within 1 week after last session)
measure: Patient Comfort and Tolerability of the VR Headset as Measured by an 8-Item Adapted Scale
timeFrame: Post-intervention (Week 12, within 1 week after last session)
measure: Clinician Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
timeFrame: Post-intervention (Week 12, within 1 week after last session)
measure: Clinician Perception of VR Headset Comfort for Patients as Measured by a 3-Item Questionnaire
timeFrame: Post-intervention (Week 12, within 1 week after last session)
Other outcomes:
measure: Participant Age
timeFrame: Baseline
measure: Participant Sex
timeFrame: Baseline
Locations:
city: Badalona
country: Spain
facility: Centro Socio Sanitario El Carmen
state: Barcelona
Study officials:
References:
citation: Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment Jose Ferrer Costa, Maria Jose Ciudad, Maribel González Abad, and José Luis Rodríguez García Journal of Medical Extended Reality 2025 2:1, 30-42