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Virtual Reality and Diagnostic of Attention Deficit Hyperactivity Disorder (ADHD) (PADA1)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Procedure: Virtual reality task

Study type

Interventional

Funder types

Other

Identifiers

NCT04561713
2018/33

Details and patient eligibility

About

The aim of this study is to develop an application in order to identify the most relevant cognitive and behavioral parameters for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) in conditions closer to reality

Full description

Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in school-aged children. This disorder is characterized by a symptomatic triad associating, inattention, hyperactivity and impulsivity. Cognitive, emotional and behavioral dysfunctions have a strong impact on the school, family and social domains of the child. The clinical diagnosis of ADHD is all the more difficult because there are currently no biological, clinical or psychological markers that accurately measure the symptoms of ADHD. The diagnosis is made during interviews with specialist doctors allowing the collection of information from parents and the child. Virtual reality technology is most recognized as a tool for assessment, rehabilitation of cognitive processes and functional skills. In addition to traditional diagnostic assessment methods, a virtual reality application in an immersive room (CAVE) in three dimensions could objectively assess the child in a dynamic environment that is as close as possible to everyday situations

Enrollment

30 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Group of children with ADHD :

  • Children aged 8 to 12 diagnosed with ADHD (according to DSM-V criteria)
  • Positive ADHD diagnosis with standardized maintenance of Kiddie-Sads
  • Naïve drug treatment for ADHD
  • Schooled in a classic environment
  • Intellectual Quotient> 80 (4 subtests of WASI, or WISC IV-R / WISC-V less than 2 years old)
  • Having French as mother tongue
  • Children benefiting from a social security scheme
  • Signing of free, informed and written consent by the child and the holders of parental authority Group of children controls

Children aged 8 to 12 years undiagnosed ADHD (according to DSM-V criteria) :

  • Not presenting with ADHD at standardized maintenance Kiddie-Sads
  • Schooled in a classic environment
  • Intellectual Quotient> 80 (4 subtests of WASI)
  • Having French as mother tongue
  • Children benefiting from a social security scheme
  • Signing of free, informed and written consent by the child and the holders of parental authority

Exclusion criteria

  • Positive diagnosis with standardized maintenance of Kiddie-Sads for the following disorders: mood disorders, psychotic disorders, autism spectrum disorders, severe anxiety disorders and severe tic disorders
  • Presenting a hearing or vision diagnosis diagnosed that does not allow the task to be performed in virtual reality
  • Neurological disorders
  • Photosensitive Epilepsy (contraindication to immersion in virtual reality)
  • Treatment with psychostimulants or other psychotropic drugs
  • Unable to complete the virtual reality task during the familiarization session

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Attention Deficit Hyperactivity Disorder (ADHD)
Experimental group
Description:
Children aged 8 to 12 diagnosed with ADHD
Treatment:
Procedure: Virtual reality task
Control
Sham Comparator group
Description:
Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group
Treatment:
Procedure: Virtual reality task

Trial contacts and locations

1

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Central trial contact

Jean-Arthur MICOULAUD-FRANCHI; Cécile KLOCHENDLER

Data sourced from clinicaltrials.gov

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