Non-randomized Clinical Trial on Cognitive Stimulation With Virtual Reality in Patients With Mild Cognitive Impairment (RVEC-DCL)

Badalona Serveis Assistencials

Status: Enrolling

Conditions: Aging; Mild Cognitive Impairment; Cognitive Dysfunction

Treatments: Behavioral: Standard Cognitive Rehabilitation; Behavioral: VR-Enhanced Cognitive Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06977815

PI-24-210

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

VR-Enhanced Cognitive Rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: VR-Enhanced Cognitive Rehabilitation

Standard Cognitive Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Cognitive Rehabilitation