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)

Hopital La Musse

Status: Begins enrollment this month

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

Treatments: Other: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07371260

2025-A02119-40

Details and patient eligibility

About

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.

Enrollment: 3 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Intervention

Experimental group

Description:

VR

Treatment:

Other: Virtual reality