<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03818971</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH 2018-02</org_study_id>
    <secondary_id>IDRCB 2018-A02336-49</secondary_id>
    <nct_id>NCT03818971</nct_id>
  </id_info>
  <brief_title>Study of Retinal Function Using Electroretinogram in Regular Alcohol Users</brief_title>
  <acronym>ERICA</acronym>
  <official_title>Study of Retinal Function Using Electroretinogram in Regular Alcohol Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Psychothérapique de Nancy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Psychothérapique de Nancy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol is a major public health problem and its neurotoxic effects are, among other things,&#xD;
      responsible for altering the functioning of cerebral neurotransmission pathways.&#xD;
&#xD;
      The retina is an anatomical and developmental extension of the central nervous system. It is&#xD;
      composed of several layers of retinal neurons that share similar anatomical and functional&#xD;
      properties with brain neurons. Retinal neurons are notably equipped with a complex system of&#xD;
      neurotransmission constituted by the main neurotransmitters that are involved in the central&#xD;
      effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of&#xD;
      indirect investigation for abnormal central neurotransmission pathways following regular&#xD;
      alcohol use. It is recognized to date as a good site for investigating central abnormalities&#xD;
      in neuropsychiatric and addictive disorders.&#xD;
&#xD;
      The objective of this project is to study the retinal function using electroretinogram (ERG)&#xD;
      in regular alcohol users to isolate potential markers of cerebral neurotransmission&#xD;
      abnormalities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>mono centric study, in parallel groups, controlled, non-randomized and open</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>modification of amplitude</measure>
    <time_frame>Day 0 (=day of inclusion = the only visit of the study)</time_frame>
    <description>measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modification of implicite time parameters</measure>
    <time_frame>Day 0 (=day of inclusion = the only visit of the study)</time_frame>
    <description>measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modification of amplitude of the oscillatory potential</measure>
    <time_frame>Day 0 (=day of inclusion = the only visit of the study)</time_frame>
    <description>waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modification of implicit time of the oscillatory potential</measure>
    <time_frame>Day 0 (=day of inclusion = the only visit of the study)</time_frame>
    <description>waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modification of amplitude of the background noise</measure>
    <time_frame>Day 0 (=day of inclusion = the only visit of the study)</time_frame>
    <description>measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>alcohol consumption with alcohol use disorder (AUD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>alcohol consumption without alcohol use disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no alcohol consumption</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electroretinogram (flash, pattern and multifocal)</intervention_name>
    <description>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</description>
    <arm_group_label>alcohol consumption with alcohol use disorder (AUD)</arm_group_label>
    <arm_group_label>alcohol consumption without alcohol use disorder</arm_group_label>
    <arm_group_label>no alcohol consumption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For alcohol consumer with alcohol use disorder :&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  aged between 18 and 35 years&#xD;
&#xD;
          -  alcohol use disorder according to the DSM 5&#xD;
&#xD;
          -  affiliation to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychoactive substance consumption (other than alcohol)&#xD;
&#xD;
          -  psychiatric disease in progress according to the DSM 5&#xD;
&#xD;
          -  neurologic disease in progress&#xD;
&#xD;
          -  mental impairment making it difficult or impossible to participate to the study&#xD;
&#xD;
          -  major under guardianship or curatorship or under safeguarding of justice&#xD;
&#xD;
          -  pregnant women or feeding&#xD;
&#xD;
          -  people in emergency situation&#xD;
&#xD;
          -  participation to another interventional study&#xD;
&#xD;
          -  retinal disease in progress&#xD;
&#xD;
          -  chronic glaucoma&#xD;
&#xD;
          -  ophtalmic disease affecting the visual acuity&#xD;
&#xD;
          -  ocular infection in progress&#xD;
&#xD;
          -  urinary positive drug check the day of the inclusion&#xD;
&#xD;
          -  postive Breathalyser the day of the inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas SCHWITZER</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Psychothérapique de Nancy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Psychothérapique de Nancy</name>
      <address>
        <city>Laxou</city>
        <state>Nancy</state>
        <zip>54520</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>December 17, 2021</last_update_submitted>
  <last_update_submitted_qc>December 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>retina AND electroretinogram</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03818971
org study id: RIPH 2018-02
secondary id: IDRCB 2018-A02336-49
nct id: NCT03818971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: mono centric study, in parallel groups, controlled, non-randomized and open
primary purpose: Basic Science
masking: None (Open Label)
measure: modification of amplitude
time frame: Day 0 (=day of inclusion = the only visit of the study)
description: measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt
measure: modification of implicite time parameters
time frame: Day 0 (=day of inclusion = the only visit of the study)
description: measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond
measure: modification of amplitude of the oscillatory potential
time frame: Day 0 (=day of inclusion = the only visit of the study)
description: waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt
measure: modification of implicit time of the oscillatory potential
time frame: Day 0 (=day of inclusion = the only visit of the study)
description: waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond
measure: modification of amplitude of the background noise
time frame: Day 0 (=day of inclusion = the only visit of the study)
description: measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt
arm group label: alcohol consumption with alcohol use disorder (AUD)
arm group type: Experimental
description: 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
arm group label: alcohol consumption without alcohol use disorder
arm group type: Other
description: 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
arm group label: no alcohol consumption
arm group type: Other
description: 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
intervention type: Other
intervention name: electroretinogram (flash, pattern and multifocal)
description: 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
arm group label: alcohol consumption with alcohol use disorder (AUD)
arm group label: alcohol consumption without alcohol use disorder
arm group label: no alcohol consumption
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas SCHWITZER
role: Principal Investigator
affiliation: Centre Psychothérapique de Nancy
facility: 
country: France
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No