Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

Alcohol Use Disorder Clinical Trial

— ERICA  

Official title:

Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818971
• Other study ID #: RIPH 2018-02
• Secondary ID: IDRCB 2018-A0233
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: March 22, 2021

Study information

• Verified date: October 2021
• Source: Centre Psychothérapique de Nancy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

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

• 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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Other:
• electroretinogram (flash, pattern and multifocal)
we measured the waves a, b, oscillatory potentials, back ground noise and i for the flash ERG, the waves P50 and N95 for the pattern ERG and the P1, N1 and N2 for the multifocal ERG

Locations

Country	Name	City	State
France	Centre Psychothérapique de Nancy	Laxou	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Psychothérapique de Nancy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modification of amplitude	measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt	Day 0 (=day of inclusion = the only visit of the study)
Primary	modification of implicite time parameters	measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond	Day 0 (=day of inclusion = the only visit of the study)
Primary	modification of amplitude of the oscillatory potential	waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt	Day 0 (=day of inclusion = the only visit of the study)
Primary	modification of implicit time of the oscillatory potential	waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond	Day 0 (=day of inclusion = the only visit of the study)
Primary	modification of amplitude of the background noise	measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt	Day 0 (=day of inclusion = the only visit of the study)