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

NCT06977815 | Recruiting

• 1 other identifier: PI-24-210
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Cognitive Dysfunction; Aging

Keywords

Virtual Reality; Cognitive Rehabilitation; Older Adults; VR-Enhanced Therapy; Neurocognitive Disorders; Cognitive Stimulation; Gerontology

Outcome Measures

Primary Outcomes (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

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

• 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

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

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

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

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

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

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

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

• 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.

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

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

  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.

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

• 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.

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

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

  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).

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

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Other Outcomes (2)

• Participant Age

  Baseline

• Participant Sex

  Baseline

Study Arms (2)

VR-Enhanced Cognitive Rehabilitation

EXPERIMENTAL

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.

Behavioral: VR-Enhanced Cognitive Rehabilitation

Standard Cognitive Rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: Standard Cognitive Rehabilitation

Interventions

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.

Also known as: Virtual Reality Cognitive Support

VR-Enhanced Cognitive Rehabilitation

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.

Also known as: Computer-Based Cognitive Training

Standard Cognitive Rehabilitation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Badalona Serveis Assistencials: lead

Study Sites (1)

Centro Socio Sanitario El Carmen

Badalona, Barcelona, 08917, Spain

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders

Central Study Contacts

José Ferrer Costa, MD

CONTACT

0034935074710; jfcosta@bsa.cat

Maria Jose Ciudad Mas, MSc

CONTACT

0034935074710; mjciudad@bsa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking; participants and facilitators are aware of group allocation due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Researcher and Project Manager

Model Details: Two groups: one receiving computer-based cognitive rehabilitation with added virtual reality (VR); the other receiving computer-based cognitive rehabilitation only.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 18, 2025
• Study Start: October 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

ES (1)