REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT05391113
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Start: 2023-07-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-07-27
• Study Completion: 2027-01-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood Oxygene Level Dependent (BOLD) MRI signal	At inclusion	Measurement in fMRI of the BOLD signal for each condition (interest, addiction, social) will be carried out in order to highlight the possible alterations of the reward system, in particular at the level of the striatum in terms of cerebral activation for each of the groups of subjects. (FAD, ASD and HV).

Secondary Outcome Measures

Name	Time	Method
Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients	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 with FAD compared to ASD subjects and healthy volunteers.
Tolerance to an MRI examination for FAD with overweight or obesity	At inclusion	For the tolerance to an MRI examination for FAD with overweight or obesity: feedback on their experience in MRI.

Trial Locations

Locations (3)

Center-Val de Loire Region Autism Resource Center; 🇫🇷 Tours, France

University Addictology Service, Liaison Team and Addictology Care; 🇫🇷 Tours, France

University Hospital, Medical Imaging Service; 🇫🇷 Tours, France