REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

NCT05391113 | Recruiting

• 3 other identifiers: DR2200162022-A01098-3522-87
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Autism Spectrum Disorder

Keywords

Autism; MRI;Addictive disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerance to an MRI examination for FAD with overweight or obesity

  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

  At inclusion

Study Arms (3)

Autism Spectrum Disorder

EXPERIMENTAL

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; Diagnostic Test: EEG

Food Addictive Disorders

ACTIVE COMPARATOR

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; Diagnostic Test: EEG

Healthy volonteers

PLACEBO COMPARATOR

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

Diagnostic Test: MRI; Diagnostic Test: EEG

Interventions

MRI DIAGNOSTIC_TEST

an fMRI measurement of the BOLD physiological signal for sensory responses

Also known as: Functionnal MRI

Autism Spectrum Disorder; Food Addictive Disorders; Healthy volonteers

EEG DIAGNOSTIC_TEST

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.

Also known as: Electro Encephalography

Autism Spectrum Disorder; Food Addictive Disorders; Healthy volonteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Tours: lead
• INSERM UMR-1253, Tours, France: collaborator

Study Sites (3)

Center-Val de Loire Region Autism Resource Center

Tours, 37044, France

RECRUITING

University Addictology Service, Liaison Team and Addictology Care

Tours, 37044, France

RECRUITING

University Hospital, Medical Imaging Service

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Frédéric BRIEND, PhD

  University Hospital,Tours -INSERM U1253 iBrain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric BRIEND, PhD

CONTACT

+33247478519; frederic.briend@univ-tours.fr

Coralie TAILLEBUIS, MSc

CONTACT

+33247473909; c.taillebuis@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: July 27, 2023
• Primary Completion (Estimated): July 27, 2026
• Study Completion (Estimated): January 27, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)