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.

NCT07371260 | Not Yet Recruiting

• 1 other identifier: 2025-A02119-40
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injury; Virtual Reality; Behavior; Emotion; Well-being

Keywords

Acquired Brain Injury; Behavior; Emotion; Well-being; Virtual Reality; Multisensory; Specialized Care Home

Outcome Measures

Primary Outcomes (1)

• NPI-ES

  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 Outcomes (5)

• ECCSEG : The Geneva Scale of Socio-Emotional Behavior Changes

  in the middle and at the end of each phase of the SCED (baseline, intervention, follow-up). 6 evaluations

• The QOLIBRI Emotion Questionnaire

  Twice at baseline, twice during the intervention, and twice during follow-up (6 evaluations).

• Sensory capsule satisfaction survey

  Twice during the intervention

• The Simulator Sickness Questionnaire (SSQ)

  Twice during the intervention

• The RV Presence Questionnaire

  Twice during the intervention

Study Arms (1)

Intervention

EXPERIMENTAL

VR

Other: Virtual reality

Interventions

Virtual reality OTHER

The intervention will consist of 8 weeks with two weekly virtual relaxation sessions using the VirtySens® multisensory device, lasting 15 to 20 minutes.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital La Musse: lead

Study Sites (1)

Hôpital La Musse

Saint-Sébastien-de-Morsent, France

Location

MeSH Terms

Conditions

Brain Injuries; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Héloïse BAILLET, Dr

CONTACT

+33(0)232293047; h.baillet@hlrs-lamusse.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 27, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)