Clinical trial NCT05391113: REward SYSTem in Autism Spectrum Disorder and Addictive Disorder
Official title: Stimuli Sociaux Et Non-sociaux Du Système De Récompense : Une Étude En IRM Chez Des Sujets Avec Trouble Du Spectre De L'autisme Et Des Sujets Avec Un Trouble Addictif À L'alimentation. - RESYSTAA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism; MRI;Addictive disorders
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: INSERM UMR-1253, Tours, France
First posted: 2022-05-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study, monocentric open in three parallel groups (ASD, AD and healthy volunteers).
Primary purpose: DIAGNOSTIC

Brief summary: An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers.

Detailed description: An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers, where pathophysiology common to both disorders, based on a dysfunction of the reward system. The project we propose aims to explore the neural networks underlying these alterations in patients suffering from autism or addictive disorder.

Eligibility criteria: Inclusion Criteria:

Arm A ˗ Concerning ASD patients: Adult carrying the diagnosis of ASD (DSM-5, ADOS, ADI-R criteria)

Arm B ˗ Concerning FAD patients: Adult diagnosed with FA presenting with food addiction (DSM-5, YFAS 2.0, BES \>= 18 criteria).

Arm C ˗ Concerning healthy volunteers : Adult with no neurological and psychiatric history , absence of progressive somatic pathologies or with vital risk.

For all participants:

* Age greater than or equal to 18 years old
* Without intellectual delay (IQ \> 70).
* Able to understand and apply the instruction when an active task is proposed, according to the estimate of the investigator.
* Free, express, informed and written consent of the participant.
* Participant affiliated to a social security scheme

Exclusion Criteria:

* Neuromotor disorders.
* Visual disturbances not corrected or incompatible with MRI.
* Known epilepsy.
* Current substance use disorder with emotional distress/significant impact on functional outcome
* Rare genetic syndrome.
* Contraindications to MRI (other than body circumference)
* For women of childbearing age: negative urine or blood pregnancy test
* Person subject to a measure of judicial protection (safeguard of justice, curatorship, guardianship or family authorization)

Primary outcomes:
measure: Blood Oxygene Level Dependent (BOLD) MRI signal
timeFrame: At inclusion
Secondary outcomes:
measure: Tolerance to an MRI examination for FAD with overweight or obesity
timeFrame: At inclusion
measure: Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients
timeFrame: At inclusion
Other outcomes:
Locations:
city: Tours
country: France
facility: Center-Val de Loire Region Autism Resource Center
city: Tours
country: France
facility: University Addictology Service, Liaison Team and Addictology Care
city: Tours
country: France
facility: University Hospital, Medical Imaging Service
Study officials:
affiliation: University Hospital,Tours -INSERM U1253 iBrain
name: Frédéric BRIEND, PhD
role: PRINCIPAL_INVESTIGATOR
References: