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

R

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

Trial contacts and locations

3

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Central trial contact

Wiebe de JONG, MSc; Frédéric BRIEND, PhD

Data sourced from clinicaltrials.gov

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