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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)

R

Regional University Hospital Center (CHRU)

Status

Enrolling

Conditions

Autism Spectrum Disorder

Treatments

Behavioral: virtual reality training
Behavioral: usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT05171244
DR200078

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

8 to 16 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Experimental group
Experimental group
Treatment:
Behavioral: virtual reality training
Behavioral: usual care
Control group
Sham Comparator group
Treatment:
Behavioral: usual care

Trial contacts and locations

2

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Central trial contact

Remi CLAIRE

Data sourced from clinicaltrials.gov

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