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Clinical Trials/NCT03818971
NCT03818971
Completed
Not Applicable

Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

Centre Psychothérapique de Nancy1 site in 1 country60 target enrollmentMay 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Centre Psychothérapique de Nancy
Enrollment
60
Locations
1
Primary Endpoint
modification of amplitude
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2019
End Date
March 22, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Psychothérapique de Nancy
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged between 18 and 35 years
  • alcohol use disorder according to the DSM 5
  • affiliation to a social security scheme

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

modification of amplitude

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Day 0 (=day of inclusion = the only visit of the study)

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

Study Sites (1)

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