Brain InjuryRév In MASNCT07371260
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.
A study testing Virtual reality in people with Brain Injury and Virtual Reality, run by Hopital La Musse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Virtual Reality, Behavior
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Virtual reality
- Keywords
- Acquired Brain Injury, Behavior, Emotion, Well-being, Virtual Reality, Multisensory, Specialized Care Home
- Medical subject headings
- Brain Injuries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
The intervention will consist of 8 weeks with two weekly virtual relaxation sessions using the VirtySens® multisensory device, lasting 15 to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | VR Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice a week, for 21 weeks
Secondary outcomes (5)
ECCSEG : The Geneva Scale of Socio-Emotional Behavior Changes
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.
Measured: in the middle and at the end of each phase of the SCED (baseline, intervention, follow-up). 6 evaluations
The QOLIBRI Emotion Questionnaire
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.
Measured: Twice at baseline, twice during the intervention, and twice during follow-up (6 evaluations).
Sensory capsule satisfaction survey
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.
Measured: Twice during the intervention
The Simulator Sickness Questionnaire (SSQ)
The Simulator Sickness Questionnaire (SSQ) is currently the gold standard test for objectively measuring cybersickness.
Measured: Twice during the intervention
The RV Presence Questionnaire
The Presence Questionnaire (74): consisting of 19 items on a 7-point scale, it measures the feeling of presence.
Measured: Twice during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start30 Sep 2026
- Primary completion30 Sep 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371260
- Sponsor's protocol ID
- 2025-A02119-40
- Acronym
- Rév In MAS
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07371260
- Acronym / sponsor ID
- Rév In MAS / 2025-A02119-40
- Conditions
- Brain Injury, Virtual Reality, Behavior, Emotion, Well-being
- Keywords
- Acquired Brain Injury, Behavior, Emotion, Well-being, Virtual Reality, Multisensory, Specialized Care Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual realityVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThe intervention will consist of 8 weeks with two weekly virtual relaxation sessions using the VirtySens® multisensory device, lasting 15 to 20 minutes. | Other | Intervention |
Primary outcome
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.
5 secondary outcomes
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 QOLIBRI Emotion Questionnaire
Time frame: Twice at baseline, twice during the intervention, and twice during follow-up (6 evaluations).
Sensory capsule satisfaction survey
Time frame: Twice during the intervention
The Simulator Sickness Questionnaire (SSQ)
Time frame: Twice during the intervention
The RV Presence Questionnaire
Time frame: Twice during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Brain Injury and Virtual Reality, run by Hopital La Musse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPI-ES (time frame: Twice a week, for 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.