Effects of Virtual Reality With Multisensory Stimulation on Emotional and Behavioral Disorders in Individuals With Acquired Brain Injury and Disability Requiring Institutional Care: a Single Case Experimental Design (SCED) Study. (Rév In MAS)

January 19, 2026 updated by: Hopital La Musse

Acquired brain injuries (ABIs) frequently cause emotional and behavioral disorders that impair independence and quality of life, particularly in institutions. Virtual reality (VR), already used in various mental and neurological disorders, offers therapeutic potential that remains largely unexplored in this context.

Multisensory devices offer enhanced immersion that can potentially increase the relaxation and calming effect. Their use in specialized care home (SCH) could provide additional support for care.

The main objective of the study is to measure the effect of an 8-week multisensory VR relaxation program on the most significant emotional and behavioral disorders in adults with acquired brain injury living in SCH. The SCED method with multiple baselines across subjects (ABA) is used with three adult residents with ABCI and behavioral disorders living in SCH. The study consists of three phases (baseline, intervention, follow-up), during which the three main emotional and behavioral disorders of each resident are assessed weekly based on observations made throughout the week. Additional measures include the assessment of the socio-emotional profile by the care team (ECCSEG) and the emotional distress experienced by residents (QOLIBRI), collected twice per phase. The intervention consists of eight weeks of VR relaxation (VirtySens®), with two 15-minute sessions per week.

All measurements taken during the experiment will be anonymized and used only by the investigators, who are fully aware of the European GDPR (General Data Protection Regulation) concerning the protection of personal data.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Resident aged over 18
  • Diagnosis of stroke, traumatic brain injury, tumor, or cerebral anoxia for more than 3 years.
  • Living in a nursing home for at least 6 months
  • Presence of one or more emotional and behavioral disorders during initial assessments (NPI-ES) for at least 3 months.
  • Sufficient cognitive abilities to understand instructions and answer questions using a Likert scale.
  • Normal or corrected visual acuity
  • Resident affiliated with the social security system

Exclusion Criteria:

  • Motor or sensory disorders incompatible with the use of VR
  • Unstabilized photosensitive epilepsy or presence of a seizure in the past year
  • Change in the prescription of neuroleptic treatments, antidepressants, benzodiazepines, sedatives, anxiolytics, mood stabilizers, antiepileptics, or betablockers within the last 3 months.
  • Unstabilized major psychiatric disorders.
  • Craniectomy
  • Limited range of cervical movement due to orthopedic disorders
  • Moderate or severe hearing loss not compensated by a hearing aid
  • Anosmia
  • Asthma
  • Pregnant women or women suspected of being pregnant
  • Breastfeeding women
  • Neurocognitive disorders preventing understanding of instructions during assessments
  • The resident is included in another research protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
VR
Other: Virtual reality
The intervention will consist of 8 weeks with two weekly virtual relaxation sessions using the VirtySens® multisensory device, lasting 15 to 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPI-ES
Time Frame: Twice a week, for 21 weeks

The primary outcome measure is the weekly NPI-ES score, calculated for the three most prominent emotional and behavioral disturbances in each participant.

This score is calculated from systematic observations made daily over five consecutive days, during two standardized periods of the day: (1) lunch and (2) a group activity in the afternoon.
Twice a week, for 21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECCSEG : The Geneva Scale of Socio-Emotional Behavior Changes
Time Frame: in the middle and at the end of each phase of the SCED (baseline, intervention, follow-up). 6 evaluations
The Geneva Socio-Emotional Behavior Change Scale (ECCSEG) was developed by Beni et al. (2017) to assess socio-emotional disorders frequently encountered after a TBI, although it can also be used in other etiological contexts. The ECCSEG questionnaire is completed by the neuropsychologist together with the care team, which includes at least one registered nurse, one nursing assistant or medical-psychological assistant, one special education teacher, and one psychomotor therapist during weekly team meetings. The team agrees to evaluate the 22 items on each participant's questionnaire. A total score is then calculated by adding up all the scores per item. The ECCSEG questionnaire is completed twice per phase: midway through and at the end of the phase.
in the middle and at the end of each phase of the SCED (baseline, intervention, follow-up). 6 evaluations
The QOLIBRI Emotion Questionnaire
Time Frame: Twice at baseline, twice during the intervention, and twice during follow-up (6 evaluations).
The QOLIBRI Emotion Questionnaire is a tool specifically designed for people with brain injuries, which aims to gather subjective perceptions of patients' quality of life.
Twice at baseline, twice during the intervention, and twice during follow-up (6 evaluations).
Sensory capsule satisfaction survey
Time Frame: Twice during the intervention

Each resident is asked:

"Are you satisfied with using the sensory capsule? On a scale of 1 to 5 (Likert). 1 = Not at all; 2 = A little; 3 = Moderately; 4 = Quite a lot; 5 = Very much." Why? Residents will answer this question twice during the intervention.
Twice during the intervention
The Simulator Sickness Questionnaire (SSQ)
Time Frame: Twice during the intervention
The Simulator Sickness Questionnaire (SSQ) is currently the gold standard test for objectively measuring cybersickness.
Twice during the intervention
The RV Presence Questionnaire
Time Frame: Twice during the intervention
The Presence Questionnaire (74): consisting of 19 items on a 7-point scale, it measures the feeling of presence.
Twice during the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital La Musse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A02119-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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