Autism Spectrum DisorderSEVIRENCT05171244
Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)
A study testing virtual reality training in people with Autism Spectrum Disorder, run by University Hospital, Tours at 2 sites in France.
Trial summary
Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- virtual reality training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Mar 2022to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child / adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).
- Without intellectual delay (QNV> 70, WISC-IV or V, WAIS-III or IV).
- Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).
- Schooled in the ordinary school context (primary school, middle school, high school, ULIS).
- Having expressed their agreement to participate in the study.
- Whose parents or legal representatives have signed written consent.
- Whose parents or legal representatives are affiliated or beneficiaries of a social security scheme.
Who cannot join
- Neuromotor disorders.
- Uncorrected visual disorders.
- Hearing impairment.
- Known epilepsy.
- Anxiety syndromes identified.
- Hyper ADD / H type activity.
- Treatment with methylphenidate. - Rare genetic syndrome.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Le Centre universitaire de pédopsychiatrie
Tours, Tours, 37000
- Not yet recruiting
Pedopsychiatry, University Hospital, Tours
Tours, 37044
Remi CLAIRE, 02 47 47 88 47 ext. +33, r.claire@chu-tours.fr
About this study
Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.
Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.
The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.
- Conditions
- Autism Spectrum Disorder
- Being tested
- virtual reality training, usual care
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality trainingBehavioural
training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care
usual careBehavioural
usual program of interventions in usual care
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: virtual reality training; Behavioral: usual care |
| Control group | Sham comparator | Not described Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vineland Adaptive Behavior Scales II (VABS II) score
Behavioral scale VABS II is a test for assessing autonomy of child/adolescent in everyday life. From 0 to 108, higher is the score, more independent the person is in the rated field.
Measured: Baseline, week 15 (after training), 6 months after training
Secondary outcomes (6)
Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)
ECA2 provides an assessment of the current extent of the child's behavioral characteristics. Scale reportes a score from 0 to 4, 5 levels according to the current importance of these behaviors (0 :absent - 4 :very serious)
Measured: Baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)
ECA2P provides an assessment of the current extent of the child's behavioral characteristics. Scale reportes a score from 0 to 4, 5 levels according to the current importance of these behaviors (0 :absent - 4 :very serious)
Measured: baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Dunn sensory profile
Dunn sensory profile is completed by the parents. From 0 to 110, higher is the score more important is the comportement
Measured: Baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)
VABS-II provides an assessment of problematic behaviour. From 0 to 108, higher is the score, more independent the person is in the rated field.
Measured: Baseline, week 15 (after training), 6 months after training
Cognitive rigidity measure
Neuropsycological tests
Measured: Baseline, week 15 (after training), 6 months after training
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)
Evaluation of intensity scores for signs of stereotyped and repetitive activity on the EC2R.Factor sensory-motor stereotypies is evaluated by a score from 0 to 44. Factor reaction to change and modulating insufficiency factor are evaluated by a score from 0 to 28. Factor restricted behaviors is evaluated by a score from 0 to 32. Higher is the score more important is the severity.
Measured: Baseline, week 15 (after training), 6 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start3 Mar 2022
- Primary completionOct 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center Randomized Pilot Study in Parallel Groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171244
- Sponsor's protocol ID
- DR200078
- Acronym
- SEVIRE
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)
- ClinicalTrials.gov ID
- NCT05171244
- Acronym / sponsor ID
- SEVIRE / DR200078
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Dec 2021 (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.
Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.
Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.
The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center Randomized Pilot Study in Parallel Groups
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: virtual reality training, Behavioral: usual care |
| Control group | Sham comparator | Behavioral: usual care |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child / adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).
- Without intellectual delay (QNV> 70, WISC-IV or V, WAIS-III or IV).
- Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).
- Schooled in the ordinary school context (primary school, middle school, high school, ULIS).
- Having expressed their agreement to participate in the study.
Key exclusion criteria (7 listed)
- Neuromotor disorders.
- Uncorrected visual disorders.
- Hearing impairment.
- Known epilepsy.
- Anxiety syndromes identified.
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 reality trainingtraining of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care | Behavioural | Experimental group |
| usual careusual program of interventions in usual care | Behavioural | Control group, Experimental group |
Primary outcome
Vineland Adaptive Behavior Scales II (VABS II) score
Time frame: Baseline, week 15 (after training), 6 months after training
Behavioral scale VABS II is a test for assessing autonomy of child/adolescent in everyday life. From 0 to 108, higher is the score, more independent the person is in the rated field.
6 secondary outcomes
Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)
Time frame: Baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)
Time frame: baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Dunn sensory profile
Time frame: Baseline, week 15 (after training), 6 months after training
Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)
Time frame: Baseline, week 15 (after training), 6 months after training
Cognitive rigidity measure
Time frame: Baseline, week 15 (after training), 6 months after training
Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)
Time frame: Baseline, week 15 (after training), 6 months after training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality training in people with Autism Spectrum Disorder, run by University Hospital, Tours at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remi CLAIRE (02 47 47 88 47 ext. +33, r.claire@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vineland Adaptive Behavior Scales II (VABS II) score (time frame: Baseline, week 15 (after training), 6 months after training). 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 11 Jun 2026.