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临床试验/NCT03818971
NCT03818971已完成不适用

Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

Centre Psychothérapique de Nancy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
modification of amplitude

研究概览

简要总结

Alcohol is a major public health problem and its neurotoxic effects are, among other things, responsible for altering the functioning of cerebral neurotransmission pathways.

The retina is an anatomical and developmental extension of the central nervous system. It is composed of several layers of retinal neurons that share similar anatomical and functional properties with brain neurons. Retinal neurons are notably equipped with a complex system of neurotransmission constituted by the main neurotransmitters that are involved in the central effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of indirect investigation for abnormal central neurotransmission pathways following regular alcohol use. It is recognized to date as a good site for investigating central abnormalities in neuropsychiatric and addictive disorders.

The objective of this project is to study the retinal function using electroretinogram (ERG) in regular alcohol users to isolate potential markers of cerebral neurotransmission abnormalities.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For alcohol consumer with alcohol use disorder :
  • •Inclusion Criteria:
  • •aged between 18 and 35 years
  • •alcohol use disorder according to the DSM 5
  • •affiliation to a social security scheme

排除标准

  • •psychoactive substance consumption (other than alcohol)
  • •psychiatric disease in progress according to the DSM 5
  • •neurologic disease in progress
  • •mental impairment making it difficult or impossible to participate to the study
  • •major under guardianship or curatorship or under safeguarding of justice
  • •pregnant women or feeding
  • •people in emergency situation
  • •participation to another interventional study
  • •retinal disease in progress
  • •chronic glaucoma
  • •ophtalmic disease affecting the visual acuity
  • •ocular infection in progress
  • •urinary positive drug check the day of the inclusion
  • •postive Breathalyser the day of the inclusion

研究组 & 干预措施

alcohol consumption with alcohol use disorder (AUD)

Experimental

subjects with regular alcohol consumption with AUD according to the DSM 5 without any other substance use disorder (except alcohol) without psychiatric, neurologic or ophthalmologic disease in progress with a negative drug check and Breathalyzer the day of the inclusion - only one visit is planned for this study : an electroretinogram will be realized

干预措施: electroretinogram (flash, pattern and multifocal) (Other)

alcohol consumption without alcohol use disorder

Other

subjects with regular alcohol consumption without AUD according to the DSM 5 without any other substance use disorder without psychiatric, neurologic or ophthalmologic disease in progress with a negative drug check and Breathalyzer the day of the inclusion - only one visit is planned for this study : an electroretinogram will be realized

干预措施: electroretinogram (flash, pattern and multifocal) (Other)

no alcohol consumption

Other

subjects without alcohol consumption without any other substance use disorder without psychiatric, neurologic or ophthalmologic disease in progress with a negative drug check and Breathalyzer the day of the inclusion - only one visit is planned for this study : an electroretinogram will be realized

干预措施: electroretinogram (flash, pattern and multifocal) (Other)

结局指标

主要结局

modification of amplitude

时间窗: Day 0 (=day of inclusion = the only visit of the study)

measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt

modification of implicite time parameters

时间窗: Day 0 (=day of inclusion = the only visit of the study)

measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond

modification of amplitude of the oscillatory potential

时间窗: Day 0 (=day of inclusion = the only visit of the study)

waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt

modification of implicit time of the oscillatory potential

时间窗: Day 0 (=day of inclusion = the only visit of the study)

waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond

modification of amplitude of the background noise

时间窗: Day 0 (=day of inclusion = the only visit of the study)

measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt

次要结局

未报告次要终点

研究者

发起方
Centre Psychothérapique de Nancy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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