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

Mild Cognitive Impairment Clinical Trial

— RTCSSC  

Official title:

Desarrollo y evaluación de Experiencias en Realidad Virtual Para la estimulación Cognitiva en el Centro Sociosanitario El Carme de Badalona Servicios Asistenciales (BSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06155721
• Other study ID #: PI-23-195
• Status: Completed
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: March 27, 2024

Study information

• Verified date: April 2024
• Source: Badalona Serveis Assistencials
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background:

Cognitive impairment affects a significant portion of the aging population, leading to challenges in daily functioning and a reduced quality of life. Traditional cognitive rehabilitation techniques have shown benefits, but patient engagement and adherence remain challenging. Innovations such as virtual reality (VR) offer new avenues for cognitive stimulation, potentially enhancing patient involvement and treatment outcomes.

Study Design:

This clinical trial aims to evaluate the acceptability and efficacy of a VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment at Centro Sociosanitario El Carme in Badalona. It will employ a pretest-posttest design to assess cognitive changes, utilizing standardized cognitive scales and gathering qualitative feedback on user experience.

Objectives:

Primary Objective: To assess the acceptability of the VR-based cognitive stimulation program among patients with mild to moderate cognitive impairment.

Secondary Objectives:

To evaluate whether the VR interventions are perceived as engaging and motivating by the patients, which would suggest positive adherence to the cognitive stimulation program.

To measure changes in cognitive performance, particularly in attention and memory, pre- and post-intervention, to determine the effectiveness of the program.

To understand healthcare professionals' perceptions of the applicability of VR interventions in clinical practice for cognitive stimulation.

To identify potential improvements for the implementation of the VR program based on patient and healthcare staff feedback.

To gather data that could be useful for the development of future VR experiences aimed at patients with cognitive impairments.

Methodology:

Participants will be recruited from the Centro Sociosanitario El Carme and will undergo an initial assessment to establish a cognitive baseline. The participants will then engage in a series of VR sessions designed to provide cognitive stimulation. The program will focus on exercises to enhance attention and memory, incorporating interactive elements to maintain engagement. After completing the sessions, participants will be re-assessed using the same cognitive scales.

Feedback on the VR experience will be collected through structured interviews and questionnaires to gauge acceptability, perceived usefulness, and motivation. Healthcare professionals involved in the administration of the VR program will also be interviewed to understand their views on the integration of VR into therapeutic practices.

Expected Outcomes:

It is hypothesized that the VR program will be well-received by patients, evidenced by high rates of program completion and positive subjective feedback. Post-intervention improvements in cognitive scale scores are expected, indicating the potential efficacy of VR-based stimulation. Insights from healthcare professionals are anticipated to highlight the practicality of VR in clinical settings and suggest improvements for future applications.

Relevance:

The findings from this trial could support the adoption of VR technologies in cognitive rehabilitation, offering a novel, scalable, and potentially more effective approach to managing cognitive impairments. The study may also contribute to the evidence base required for integrating technological innovations into standard healthcare practice.

Conclusion:

By exploring the intersection of VR technology and cognitive rehabilitation, this study seeks to advance the understanding of innovative treatments for cognitive impairments and foster improved patient outcomes through enhanced engagement and stimulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Participants must be classified as having mild cognitive impairment with a Mini-Mental State Examination (MMSE) score greater than 23.

• Participants must be currently attending cognitive rehabilitation sessions at the Day Hospital of the Centro Sociosanitario El Carme (CSSC).

• Participants must be able to give informed consent or, in the case of incapacity, consent must be obtained from their legal representative.

Exclusion Criteria:

• Patients with a severe or unstable illness that could interfere with participation in the study.

• Patients with serious psychiatric disorders, such as psychotic disorders, delusions, or hallucinations that may be exacerbated by the use of virtual reality.

• Patients with severe visual limitations that would prevent the use of virtual reality.

• Presence of ocular diseases causing blurred vision that cannot be corrected with contact lenses or glasses.

• Presence of auditory pathologies that cause a significant decrease in hearing without hearing aids.

• High sensitivity to motion sickness.

• Subjects with epilepsy.

• Patients who are unable or unwilling to give informed consent.

Withdrawal Criteria

The emergence of health problems that could interfere with the continuity of participation in the study, or the withdrawal of consent by the participant.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Virtual Reality Cognitive Stimulation Program
Intervention Type: Device Intervention Name: Virtual Reality Cognitive Stimulation Program Description: This program utilizes virtual reality to conduct cognitive stimulation exercises aimed at improving memory, executive functions, and attention in individuals with Mild Cognitive Impairment (MCI). It includes interactive tasks such as virtual shopping, payment simulations, and recipe sequencing, along with 360-degree video sessions for attention and episodic memory training.

Locations

Country	Name	City	State
Spain	Centro Socio Sanitario El Carmen	Badalona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Badalona Serveis Assistencials	Public Health Agency of Barcelona, Reality Telling SL

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Bauer ACM, Andringa G. The Potential of Immersive Virtual Reality for Cognitive Training in Elderly. Gerontology. 2020;66(6):614-623. doi: 10.1159/000509830. Epub 2020 Sep 9. — View Citation

Gomez-Caceres B, Cano-Lopez I, Alino M, Puig-Perez S. Effectiveness of virtual reality-based neuropsychological interventions in improving cognitive functioning in patients with mild cognitive impairment: A systematic review and meta-analysis. Clin Neuropsychol. 2023 Oct;37(7):1337-1370. doi: 10.1080/13854046.2022.2148283. Epub 2022 Nov 23. — View Citation

Liao YY, Chen IH, Lin YJ, Chen Y, Hsu WC. Effects of Virtual Reality-Based Physical and Cognitive Training on Executive Function and Dual-Task Gait Performance in Older Adults With Mild Cognitive Impairment: A Randomized Control Trial. Front Aging Neurosci. 2019 Jul 16;11:162. doi: 10.3389/fnagi.2019.00162. eCollection 2019. — View Citation

Munoz J, Mehrabi S, Li Y, Basharat A, Middleton LE, Cao S, Barnett-Cowan M, Boger J. Immersive Virtual Reality Exergames for Persons Living With Dementia: User-Centered Design Study as a Multistakeholder Team During the COVID-19 Pandemic. JMIR Serious Games. 2022 Jan 19;10(1):e29987. doi: 10.2196/29987. — View Citation

Papaioannou T, Voinescu A, Petrini K, Stanton Fraser D. Efficacy and Moderators of Virtual Reality for Cognitive Training in People with Dementia and Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2022;88(4):1341-1370. doi: 10.3233/JAD-210672. — View Citation

Perra A, Riccardo CL, De Lorenzo V, De Marco E, Di Natale L, Kurotschka PK, Preti A, Carta MG. Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies. Int J Environ Res Public Health. 2023 Jan 14;20(2):1527. doi: 10.3390/ijerph20021527. — View Citation

Qiu R, Gu Y, Xie C, Wang Y, Sheng Y, Zhu J, Yue Y, Cao J. Virtual reality-based targeted cognitive training program for Chinese older adults: A feasibility study. Geriatr Nurs. 2022 Sep-Oct;47:35-41. doi: 10.1016/j.gerinurse.2022.06.007. Epub 2022 Jul 12. — View Citation

Zuschnegg J, Schoberer D, Haussl A, Herzog SA, Russegger S, Ploder K, Fellner M, Hofmarcher-Holzhacker MM, Roller-Wirnsberger R, Paletta L, Koini M, Schussler S. Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. BMC Geriatr. 2023 Apr 12;23(1):229. doi: 10.1186/s12877-023-03941-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics Variables	Age: numeric	Baseline
Other	Demographics Variables	Gender: 0=female, 1=male, 3=others	Baseline
Primary	Usability of VR Exercises as Measured by an Adapted 8-Item SUS:	Adapted 8-Item System Usability Scale (SUS): Score Range: 8 to 40 points Interpretation: Higher scores indicate better usability.	immediately post-intervention, within 30 minutes after the last intervention session- 8th session (day 8)
Primary	Comfort of VR Headset as Measured by an 8-Item SUS:	Adapted 8-Item VR Headset Comfort Rating: Score Range: 8 to 40 points Interpretation: Lower scores indicate better comfort (as most items measure discomfort).	immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Professional´s Usability of VR Exercises as Measured by an Adapted 8-Item SUS:	Scale Title: Professional System Usability Scale (SUS) Score Range: 8 to 40 points Interpretation: Higher scores indicate a professional's perception of better system usability for patient care.	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	VR Headset Comfort Rating for Professionals as Measured by an Adapted 3-Item SUS:	Scale Title: Professional System Usability Scale (SUS) Score Range: 3 to 15 points Interpretation: Lower scores indicate better comfort and ease of use for the VR headset; higher 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.	immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Global cognition state as measured by the MMSE	MMSE: Mini mental State Examination. Score Range: 0 to 30 points. Higher scores means better global cognition function	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Global cognition state as measured by the MoCA	MoCA: Montreal Cognitive Assessment. Score Range: 0 to 30 points; - Higher scores means better global cognition function	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Short Term Verbal Memory as measured by DST (forward span)	DST (forward span): Digit Span Test (forward span). Score Range: 0 to 9 points; - Higher scores indicate better short-term verbal memory.	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Working Memory as measure by the DST (backward span)	DST (backward span): Digit Span Test (backward span). Score Range: 0 to 9 points. Higher scores indicate better working memory.	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Visuospatial Attention as measured by the TMTA	TMTA: Trial Making Test A. Score Range: Time to complete the test, typically ranging from several seconds to several minutes.; Lower times (faster completion) indicate better visuospatial attention.	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Alternating Attention as measured by the TMTB	TMTB: Trial Making Test B. Score Range: Time to complete the test, typically ranging from several seconds to several minutes.; Lower times (faster completion) indicate better alternating attention.	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)
Secondary	Processing Speed as measured by the SDMT	SDMT: Symbol Digit Modalities Test. Score Range: Number of correct substitutions within a set time limit (90 seconds), ranging from 0 to a maximum that can vary based on the individual's speed.; Higher scores means better Processing Speed	Baseline and immediately post-intervention, within 30 minutes after the 8th session (day 8)

External Links

•   Organización de las Naciones Unidas. (2015). World population ageing. Department of Economic and Social Affairs, Population Division.
•   Organización Mundial de la Salud. (2023). Demencia, 15 de marzo de 2023. Datos y cifras.