NCT06155721: RTCSSC

Development and Evaluation of Virtual Reality Experiences for Cognitive Stimulation at the Sociosanitary Center El Carme

Completed NA Results posted Last updated 23 May 2025

What this trial tests

NA trial testing Virtual Reality Cognitive Stimulation Program in Cognitive Dysfunction in 45 participants. Completed in 27 March 2024.

Timeline

30 October 2023

Primary endpoint
27 February 2024

27 March 2024

Quick facts

Lead sponsor	Badalona Serveis Assistencials
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	45
Start date	30 October 2023
Primary completion	27 February 2024
Estimated completion	27 March 2024
Sites	1 location across Spain

Drugs / interventions tested

• Virtual Reality Cognitive Stimulation Program

Conditions studied

• Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

Badalona Serveis Assistencials

Who can join

60 and older, any sex, with Cognitive Dysfunction or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Usability of VR Exercises as Measured by an Adapted 8-Item System Usability Scale (SUS) Primary · immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)

Adapted 8-Item System Usability Scale (SUS): Score Range: 0 to 100 points Interpretation: Higher scores indicate better usability.

Group	Value	95% CI
Virtual Reality Cognitive Stimulation Program	81.9	± 14.9

Comfort of VR Headset as Measured by an 8-Item SUS: Primary · immediately post-intervention, within 30 minutes after the 8th session (day 8)

Adapted 8-Item VR Headset Comfort Rating: Score Range: 0 to 100 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort).

Group	Value	95% CI
Virtual Reality Cognitive Stimulation Program	86.5	± 13.3

Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS: Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate a professional's perception of better system usability for patient care.

Group	Value	95% CI
Virtual Reality Cognitive Stimulation Program	85.2	± 10.9

VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS: Secondary · immediately post-intervention, within 30 minutes after the 8th session (day 8)

Scale Title: Professional System Usability Scale (SUS) Score Range: 0 to 100 points Interpretation: Higher scores indicate better comfort and ease of use for the VR headset; lower scores indicate greater discomfort and difficulty with use. This rating is based on a professional assessment of the VR headset's weight, design, and control scheme's impact on patient comfort during use.

Group	Value	95% CI
Virtual Reality Cognitive Stimulation Program	60.4	± 22.9

Global Cognition as Measured by the Mini-Mental State Examination (MMSE) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

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

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	26	± 2.12
Post-Intervention - Virtual Reality Cognitive Stimulation Program	26.5	± 2.3

Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

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

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	19	± 4.19
Post-Intervention - Virtual Reality Cognitive Stimulation Program	20	± 4.4

Short-Term Memory as Measured by the Digit Span Test (DST Forward Span) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

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

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	4.5	± 1.1
Post-Intervention - Virtual Reality Cognitive Stimulation Program	4.5	± 0.96

Working Memory as Measured by the Digit Span Test (DST Backward Span) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

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

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	3	± 0.97
Post-Intervention - Virtual Reality Cognitive Stimulation Program	3	± 0.77

Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

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.

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	70.5	± 50.4
Post-Intervention - Virtual Reality Cognitive Stimulation Program	65.5	± 38.3

Executive Function as Measured by the Trail Making Test Part B (TMT-B) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

TMTB: Trial Making Test B. Score Range: Time to complete the test measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention.

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	195.5	± 421
Post-Intervention - Virtual Reality Cognitive Stimulation Program	205	± 426

Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT) Secondary · Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

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.

Group	Value	95% CI
Baseline - Virtual Reality Cognitive Stimulation Program	17	± 9.8
Post-Intervention - Virtual Reality Cognitive Stimulation Program	18.5	± 9.5

Demographics Variables Secondary · Baseline

Age: numeric

Group	Value	95% CI
Virtual Reality Cognitive Stimulation Program	75.5	± 6.19

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over a 3-month period during the pilot study.. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Virtual Reality Cognitive Stimulation Program

Serious: 0/45 (0%)

Deaths: 0/45

Other adverse events (1 terms — click to expand)

Reaction	System	Virtual Reality Cognitive …
Cybersickness	Ear and labyrinth disorders	—

Data from ClinicalTrials.gov NCT06155721 adverse events section.

Sponsor's own description

The goal of this clinical trial is to test a virtual reality (VR)-based program designed for cognitive stimulation in individuals attending the conventional cognitive rehabilitation program at the Day Hospital of CSSC (Centro Sociosanitario El Carme) in Badalona, Spain. The trial will specifically assess VR's impact on declarative memory and executive functions through interactive exercises, as well as attention and episodic memory through VR video stimuli.

The main questions it aims to answer are:

* Will patients with mild cognitive impairment find the VR program enjoyable and easy to use?
* Can VR interventions help improve patients' cognitive functions, specifically attention and memory?
* Do healthcare professionals find VR a practical tool for cognitive stimulation in their clinical practice?

Participants will undergo a series of 8 sessions, scheduled twice a week to coincide with the conventional rehabilitation appointments. The VR equipment used will be Oculus Quest 2 headsets, offering an immersive experience with hand-tracking technology that simplifies interactions, particularly beneficial for those with mild cognitive impairment (MCI). During the study, participants will:

* Engage with a VR-based cognitive stimulation program.
* Undergo assessments of the participants´ cognitive functions before and after the intervention.
* Provide feedback on the participants´ experience with the VR program.

Researchers will analyze the data to see if:

* The VR program leads to noticeable improvements in the cognitive abilities of participants.
* The program is well-received and deemed beneficial by both patients and healthcare professionals.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.