Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05171244

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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Le Centre universitaire de pédopsychiatrie, Tours, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Neuromotor disorders.
  • Uncorrected visual disorders.
  • Hearing impairment.
  • Known epilepsy.
  • Anxiety syndromes identified.
  • Hyper ADD / H type activity.
  • Treatment with methylphenidate. - Rare genetic syndrome.

Treatment and study plan

Virtual Reality Training

Behavioral

training of multisensory processing capacities in virtual reality in addition to usual program of interventions in usual care

Usual Care

Behavioral

usual program of interventions in usual care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Measures of autistic behaviour by Autism Behavior Rating Scale (ECA2)

    Time frame: Baseline, week 15 (after training), 6 months after training

    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)

  2. Measures of autistic behaviour by Autism Behavior Rating Scale for Parents (ECA2P)

    Time frame: baseline, week 15 (after training), 6 months after training

    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)

  3. Measures of autistic behaviour by Dunn sensory profile

    Time frame: Baseline, week 15 (after training), 6 months after training

    Dunn sensory profile is completed by the parents. From 0 to 110, higher is the score more important is the comportement

  4. Measures of autistic behaviour by Vineland Adaptive Behavior Scales II (VABS II)

    Time frame: Baseline, week 15 (after training), 6 months after training

    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.

  5. Cognitive rigidity measure

    Time frame: Baseline, week 15 (after training), 6 months after training

    Neuropsycological tests

  6. Cognitive rigidity measure by rating scale of repeated en restricted behaviours (EC2R)

    Time frame: Baseline, week 15 (after training), 6 months after training

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Remi CLAIRE

CONTACT

[email protected]

02 47 47 88 47 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: SEVIRE

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 28, 2021
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.