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

NCT ID: NCT06977815

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2026-03-31

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).

Conditions

Mild Cognitive Impairment; Cognitive Dysfunction; Aging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VR-Enhanced Cognitive Rehabilitation

Participants receive a computer-based cognitive rehabilitation program supplemented with immersive virtual reality exercises. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions.

Group Type: EXPERIMENTAL

VR-Enhanced Cognitive Rehabilitation

Intervention Type: 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.

Standard Cognitive Rehabilitation

Participants receive a standard computer-based cognitive rehabilitation program. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions.

Group Type: ACTIVE_COMPARATOR

Standard Cognitive Rehabilitation

Intervention Type: 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.

Interventions

VR-Enhanced Cognitive Rehabilitation

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.

Intervention Type: BEHAVIORAL

Standard Cognitive Rehabilitation

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Virtual Reality Cognitive Support; Computer-Based Cognitive Training

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Badalona Serveis Assistencials

OTHER

Sponsor Role: lead

Responsible Party

Jose Ferrer Costa

Medical Researcher and Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Socio Sanitario El Carmen

Badalona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

José Ferrer Costa, MD

Role: CONTACT

jfcosta@bsa.cat

0034935074710

Maria Jose Ciudad Mas, MSc

Role: CONTACT

mjciudad@bsa.cat

0034935074710

Facility Contacts

Maria Jose Ciudad

Role: primary

mjciudad@bsa.cat

+34935074710

References

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

Reference Type: BACKGROUND

Other Identifiers

PI-24-210

Identifier Type: -

Identifier Source: org_study_id