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

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MRI

EEG

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring Autism; MRI;Addictive disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 (verified via the MINI-S), 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 (MINI-S substance list) 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)

Sites / Locations

Center-Val de Loire Region Autism Resource CenterRecruiting
University Addictology Service, Liaison Team and Addictology CareRecruiting
University Hospital, Medical Imaging ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Autism Spectrum Disorder

Food Addictive Disorders

Healthy volonteers

Arm Description

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.

Characterized by regroup substance use disorders and behavioral addictions, are characterized in particular by the repeated occurrence of compulsive behavior and impaired social functioning

Adult without neurological and psychiatric history, absence of progressive somatic pathologies or with vital risk.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05391113

First Posted

May 20, 2022

Last Updated

July 28, 2023

Sponsor

University Hospital, Tours

Collaborators

INSERM UMR-1253, Tours, France

1. Study Identification

Unique Protocol Identification Number

NCT05391113

Brief Title

REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 27, 2023 (Actual)

Primary Completion Date

July 27, 2026 (Anticipated)

Study Completion Date

January 27, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Tours

Collaborators

INSERM UMR-1253, Tours, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Autism; MRI;Addictive disorders

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Pilot study, monocentric open in three parallel groups (ASD, AD and healthy volunteers).

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Autism Spectrum Disorder

Arm Type

Experimental

Arm Description

Arm Title

Food Addictive Disorders

Arm Type

Active Comparator

Arm Description

Characterized by regroup substance use disorders and behavioral addictions, are characterized in particular by the repeated occurrence of compulsive behavior and impaired social functioning

Arm Title

Healthy volonteers

Arm Type

Placebo Comparator

Arm Description

Adult without neurological and psychiatric history, absence of progressive somatic pathologies or with vital risk.

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI

Other Intervention Name(s)

Functionnal MRI

Intervention Description

an fMRI measurement of the BOLD physiological signal for sensory responses

Intervention Type

Diagnostic Test

Intervention Name(s)

EEG

Other Intervention Name(s)

Electro Encephalography

Intervention Description

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 Measure Information:

Title

Blood Oxygene Level Dependent (BOLD) MRI signal

Description

Time Frame

At inclusion

Secondary Outcome Measure Information:

Title

Tolerance to an MRI examination for FAD with overweight or obesity

Description

For the tolerance to an MRI examination for FAD with overweight or obesity: feedback on their experience in MRI.

Time Frame

At inclusion

Title

Regulation of sensory, an fMRI measurement of the BOLD physiological signal for sensory responses (sensory block) in terms of brain activation in patients

Description

Time Frame

At inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frédéric BRIEND, PhD

Phone

+33247478519

frederic.briend@univ-tours.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Wiebe de JONG, MSc

Phone

+33247474680

w.dejong@chu-tours.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédéric BRIEND, PhD

Organizational Affiliation

University Hospital,Tours -INSERM U1253 iBrain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center-Val de Loire Region Autism Resource Center

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuelle HOUY-DURAND, MD-PhD

Phone

+3318370545

E.HOUY-DURAND@chu-tours.fr

First Name & Middle Initial & Last Name & Degree

Frédéric BRIEND, PhD

First Name & Middle Initial & Last Name & Degree

Marianne LATINUS, PhD

First Name & Middle Initial & Last Name & Degree

Laurent BARANTIN, PhD

First Name & Middle Initial & Last Name & Degree

Emmanuelle HOUY-DURAND, MD-PhD

Facility Name

University Addictology Service, Liaison Team and Addictology Care

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul BRUNAULT, MD-PhD

Phone

+33247474747

Ext

72882

paul.brunault@univ-tours.fr

First Name & Middle Initial & Last Name & Degree

Paul BRUNAULT, MD-PhD

Facility Name

University Hospital, Medical Imaging Service

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Philippe COTTIER, MD-PhD

Phone

+33234379615

cottier@med.univ-tours.fr

First Name & Middle Initial & Last Name & Degree

Jean-Philippe COTTIER, MD-PhD

12. IPD Sharing Statement

Plan to Share IPD

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REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

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