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NCT Number: NCT05391113

REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center-Val de Loire Region Autism Resource Center, Tours, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI

Diagnostic Test

an fMRI measurement of the BOLD physiological signal for sensory responses

Other names: Functionnal MRI

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.

Other names: Electro Encephalography

Primary outcomes

  1. Blood Oxygene Level Dependent (BOLD) MRI signal

    Time frame: At inclusion

    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 outcomes

  1. Tolerance to an MRI examination for FAD with overweight or obesity

    Time frame: At inclusion

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

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

    Time frame: 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 with FAD compared to ASD subjects and healthy volunteers.

Study contacts

Contact information is provided by the study sponsor or research team.

Coralie TAILLEBUIS, MSc

CONTACT

[email protected]

+33247473909

Frédéric BRIEND, PhD

CONTACT

[email protected]

+33247478519

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • INSERM UMR-1253, Tours, France

Registry information

Official study 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

Acronym: RESYSTAA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 25, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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