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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Diagnostic Test: EEG; Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05391113

DR220016-RESYSTAA

22-87 (Registry Identifier)

2022-A01098-35 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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 , 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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 3 patient groups, including a placebo group

Autism Spectrum Disorder

Experimental group

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.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: EEG

Food Addictive Disorders

Active Comparator group

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

Treatment:

Diagnostic Test: MRI

Diagnostic Test: EEG

Healthy volonteers

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: MRI

Diagnostic Test: EEG