跳至主要内容
临床试验/NCT05391113
NCT05391113招募中不适用

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

University Hospital, Tours6 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
78
试验地点
6
主要终点
Blood Oxygene Level Dependent (BOLD) MRI signal

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Blood Oxygene Level Dependent (BOLD) MRI signal

时间窗: 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).

次要结局

  • 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)
  • Tolerance to an MRI examination for FAD with overweight or obesity(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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