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

Overview

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.

Interventions

• Diagnostic test MRI
  an fMRI measurement of the BOLD physiological signal for sensory responses
• Diagnostic test EEG
  These tests, through videos with a social or non-social content (human presence or absence on the stereoscopic projection), will allow us to study two types of sensorialities (visual and interoceptive). Thus, it will be possible to obtain inter- and exteroceptive profiles of the participants, a direct reflection of the processing of the internal bodily sensations of the body.

Primary outcome measures

• Blood Oxygene Level Dependent (BOLD) MRI signal [Time frame: At inclusion]

Secondary outcome measures (2)

• Tolerance to an MRI examination for FAD with overweight or obesity [Time frame: At inclusion]
• Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients [Time frame: At inclusion]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 3 centers

• Center-Val de Loire Region Autism Resource Center — Tours
• University Addictology Service, Liaison Team and Addictology Care — Tours
• University Hospital, Medical Imaging Service — Tours

Identifiers

NCT: NCT05391113 · DR220016 · 2022-A01098-35 · 22-87

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗