REward SYSTem in Autism Spectrum Disorder and Addictive Disorder (RESYSTAA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: MRI; Diagnostic test: EEG

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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wiebe de JONG, MSc; Phone Number: +33247474680; Email: w.dejong@chu-tours.fr
• Study Contact Backup: Name: Frédéric BRIEND, PhD; Phone Number: +33247478519; Email: frederic.briend@univ-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • Center-Val de Loire Region Autism Resource Center
    • Contact: Emmanuelle HOUY-DURAND, MD-PhD; Phone Number: +3318370545; Email: E.HOUY-DURAND@chu-tours.fr
    • Principal Investigator: Frédéric BRIEND, PhD
    • Sub-Investigator: Marianne LATINUS, PhD
    • Sub-Investigator: Laurent BARANTIN, PhD
    • Sub-Investigator: Emmanuelle HOUY-DURAND, MD-PhD
  • Tours, France, 37044
    • Recruiting
    • University Addictology Service, Liaison Team and Addictology Care
    • Contact: Paul BRUNAULT, MD-PhD; Phone Number: 72882 +33247474747; Email: paul.brunault@univ-tours.fr
    • Sub-Investigator: Paul BRUNAULT, MD-PhD
  • Tours, France, 37044
    • Recruiting
    • University Hospital, Medical Imaging Service
    • Contact: Jean-Philippe COTTIER, MD-PhD; Phone Number: +33234379615; Email: cottier@med.univ-tours.fr
    • Sub-Investigator: Jean-Philippe COTTIER, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autism Spectrum Disorder; Characterized by two main diagnostic criteria: a socio-emotional deficit via a defect in communication and social reciprocity, and a behavioral deficit which manifests itself in repetitive behavioral patterns (stereotypes), restricted interests and/or activities.	Diagnostic test: MRI; an fMRI measurement of the BOLD physiological signal for sensory responses; Other Names: Functionnal MRI; 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.; Other Names: Electro Encephalography
Active Comparator: Food Addictive Disorders; Characterized by regroup substance use disorders and behavioral addictions, are characterized in particular by the repeated occurrence of compulsive behavior and impaired social functioning	Diagnostic test: MRI; an fMRI measurement of the BOLD physiological signal for sensory responses; Other Names: Functionnal MRI; 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.; Other Names: Electro Encephalography
Placebo Comparator: Healthy volonteers; Adult without neurological and psychiatric history, absence of progressive somatic pathologies or with vital risk.	Diagnostic test: MRI; an fMRI measurement of the BOLD physiological signal for sensory responses; Other Names: Functionnal MRI; 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.; Other Names: Electro Encephalography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Oxygene Level Dependent (BOLD) MRI signal	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).	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance to an MRI examination for FAD with overweight or obesity	For the tolerance to an MRI examination for FAD with overweight or obesity: feedback on their experience in MRI.	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	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.	At inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: INSERM UMR-1253, Tours, France
• Investigators: Principal Investigator: Frédéric BRIEND, PhD, University Hospital,Tours -INSERM U1253 iBrain

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): July 27, 2026
• Study Completion (Estimated): January 27, 2027

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Autism; MRI;Addictive disorders
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: DR220016-RESYSTAA; 2022-A01098-35 (Registry Identifier: ID RCB-ANSM); 22-87 (Registry Identifier: CPP SUD-MED IV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No