Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

NCT03818971 | Completed

• 2 other identifiers: RIPH 2018-02IDRCB 2018-A02336-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

retina AND electroretinogram

Outcome Measures

Primary Outcomes (5)

• modification of amplitude

  measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt

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

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

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

Other: electroretinogram (flash, pattern and multifocal)

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

Other: electroretinogram (flash, pattern and multifocal)

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

Other: electroretinogram (flash, pattern and multifocal)

Interventions

electroretinogram (flash, pattern and multifocal) OTHER

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

alcohol consumption with alcohol use disorder (AUD); alcohol consumption without alcohol use disorder; no alcohol consumption

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead

Study Sites (1)

Centre Psychothérapique de Nancy

Laxou, Nancy, 54520, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Thomas SCHWITZER

  Centre Psychothérapique de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mono centric study, in parallel groups, controlled, non-randomized and open

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 28, 2019
• Study Start: May 13, 2019
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)