REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

Autism Spectrum Disorder Clinical Trial

— RESYSTAA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391113
• Other study ID #: DR220016-RESYSTAA
• Secondary ID: 2022-A01098-3522
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2023
• Est. completion date: January 27, 2027

Study information

• Verified date: July 2023
• Source: University Hospital, Tours
• Contact: Frédéric BRIEND, PhD
• Phone: +33247478519
• Email: frederic.briend[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: January 27, 2027
• Est. primary completion date: July 27, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Diagnostic Test:
• MRI
an fMRI measurement of the BOLD physiological signal for sensory responses
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	INSERM UMR-1253, Tours, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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