<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/NCT03826238</url>
  </required_header>
  <id_info>
    <org_study_id>REHABOH-VG</org_study_id>
    <nct_id>NCT03826238</nct_id>
  </id_info>
  <brief_title>VR Assessment for Alcohol Related Brain Damage</brief_title>
  <official_title>Alcohol Related Brain Damage: Exploring Virtual Reality Based Cognitive Function Assessment and EEG Biomarkers. A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitat Pompeu Fabra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Bioengineering of Catalonia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitat Pompeu Fabra</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study where 10 alcohol-related brain damage (ARBD) patients will undergo a&#xD;
      30-minutes-long cognitive assessment session using the Validation Gate task to evaluate&#xD;
      usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients&#xD;
      will also be recorded and compared to the ones of age-matched healthy people in order to&#xD;
      preliminary explore the existence of possible EEG biomarkers of ARBD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Much of the burden of disease related to harmful alcohol use is due to the persistent effects&#xD;
      of alcohol on central nervous system. The concept of alcohol-related brain damage (ARBD) is&#xD;
      important in the Addiction Psychiatry field. ARBD is a spectrum of disorders. Besides most&#xD;
      severe forms, 50-70% of patients with alcohol use disorder suffer some kind of cognitive&#xD;
      impairment, being mild to moderate cognitive impairment the most frequent disorders, and&#xD;
      often the most difficult to detect. In alcoholic patients, greater cognitive impairment has&#xD;
      been associated with less treatment compliance and fewer days of abstinence. Considering its&#xD;
      impact, cognitive screening should be enhanced.&#xD;
&#xD;
      Recently, standard assessments have been augmented with new interactive technology. The work&#xD;
      group of the Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), part&#xD;
      of Institute for Bioengineering of Catalonia (IBEC), developed a virtual assessment of&#xD;
      cognitive function, called the Validation Gate task, which evaluates sustained attention,&#xD;
      working memory and executive functioning. This tool has been used so far in chronic stroke&#xD;
      patients, showing that, in this group, depression symptoms affect performance in this task.&#xD;
&#xD;
      Similarly to chronic stroke patients, a diffuse harm of several cognitive domains in ARBD is&#xD;
      observed. In the addiction psychiatry field, the gold standard to evaluate changes in&#xD;
      cognitive function are still thorough neuropsychological test batteries. But performing&#xD;
      thorough neuropsychological evaluations on all patients in daily clinical practice is highly&#xD;
      resource consuming (need of expert neuropsychologists, time consuming). These last years&#xD;
      scientific community has also been trying to find biomarkers of ARBD in electrophysiological&#xD;
      tests, with no conclusive results.&#xD;
&#xD;
      In this pilot study a small number of ARBD patients and healthy people will undergo a single&#xD;
      30-minutes-long cognitive assessment session using the Validation Gate task to evaluate&#xD;
      usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients&#xD;
      will also be recorded and compared to the ones of age-matched healthy controls in order to&#xD;
      preliminary explore the existence of possible EEG biomarkers of ARBD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virtual assessment (Validation Gate task)</measure>
    <time_frame>30 minutes</time_frame>
    <description>The Validation Gate task, a visual attention task where the patient must detect discontinuities in the moving trajectory of circles on the screen. In this task the following variables will be registered: fast and slow eye saccades as well as conscious detections.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>20 minutes</time_frame>
    <description>MoCA test is a screening test for cognitive impairment that explores 8 domains: visuospatial/executive ability, naming, memory, attention, language, abstraction, delayed recall, and orientation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>10 minutes</time_frame>
    <description>Evaluation tool of depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The summed score indicates severity (0-7 no depression, &gt; 23 very severe depression)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting State and task-dependent EEG</measure>
    <time_frame>40 minutes</time_frame>
    <description>6 minutes of EEG data during resting state and 30 minutes of EEG during the Validation Gate taks, will be acquired through the wireless sensor system ENOBIO32 of Starlab. From these recordings the mean spectral energy in the common frequency bands will be obtained as variables to identify signatures of TCD and the theta activity in the different groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The alcohol, smoking and substance involvement screening test (ASSIST)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The ASSIST scale is used to detect substance use and classify risk and severity for each substance. Each question (8 questions) on the ASSIST has a set of responses to choose from, and each response has a numerical score (for instance they can range from 0 for &quot;never&quot; to up to 8 for &quot;daily&quot;). The interviewer simply circles the numerical score that corresponds to the patient's response for each question/substance. At the end of the interview the scores for each substance are added together to produce an ASSIST score for that substance. Low numbers mean low risk, high numbers mean high risk. We are testing only for &quot;Alcohol-Risk&quot;, which can have a risk-score from 0 to 31.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use Disorders Identification Test (AUDIT)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Assessment of alcohol use</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Alcohol-Related Disorders</condition>
  <arm_group>
    <arm_group_label>ARBD and depression</arm_group_label>
    <description>10 patients with ARBD and at least moderate depressive symptoms (MoCA &lt; 26, Hamilton Depression Rating Scale ≥ 17). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARBD and no depression</arm_group_label>
    <description>10 patients with ARBD and no clinically relevant depressive symptoms (MoCA &lt; 26, Hamilton Depression Rating Scale &lt; 17). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>10 healthy controls (no ARDB, no depression, no cognitive deficit). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Validation Gate task</intervention_name>
    <description>The task is to observe several moving unfilled white circles on a dark background. The circles move in straight paths. Every so often, a randomly selected circle will displace to a point inconsistent with its trajectory, which will look like a &quot;jump&quot;. The subjects' task is to press the space bar every time they detect a displacement (e.g. jump). A session consists of 30 minutes, it starts with 2 training blocks which are followed by 2 no-cognitive load blocks and 6 blocks with increasing cognitive load conditions. During the assessment the eye movement as well as the key presses are registered in order to calculate early and late saccades as well as conscious reporting. Resting-state EEG will also be recorded and compared to the ones of age-matched healthy controls. Task-dependent EEG data will be recorded during the Validation Gate task.</description>
    <arm_group_label>ARBD and depression</arm_group_label>
    <arm_group_label>ARBD and no depression</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ARBD (Groups A and B) will be consecutively recruited from the Addiction&#xD;
        outpatient and Day Hospital Unit of Addiction Unit at the Department of Psychiatry at&#xD;
        Hospital Clínic in Barcelona.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alcohol Use Disorder (DSM 5) as main substance&#xD;
&#xD;
          -  Positive screening for alcohol related cognitive impairment (Montreal Cognitive&#xD;
             Assessment, MoCA &lt; 26)&#xD;
&#xD;
          -  abstinent during 15 to 90 days according to self-reports&#xD;
&#xD;
          -  no severe upper limb motor disability.&#xD;
&#xD;
          -  Older than 18 years old.&#xD;
&#xD;
          -  abìlity to talk, understand and write in Catalan, Spanish or English.&#xD;
&#xD;
          -  sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cognitive incapacity that prohibits the execution of the assessment&#xD;
&#xD;
          -  severe impairments like spasticity, communication disabilities (aphasia or apraxia)&#xD;
             and perceptual or physical impairments that would interfere with the correct execution&#xD;
             or understanding of the assessment&#xD;
&#xD;
          -  history of other serious mental-health problems in acute or subacute phase&#xD;
&#xD;
          -  comorbidity with severe neurological illness&#xD;
&#xD;
          -  regular use of other substances (except nicotine)&#xD;
&#xD;
          -  active intake of benzodiazepines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Martina Maier, Ms</last_name>
    <phone>722257096</phone>
    <email>mmaier@ibecbarcelona.eu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Belén Rubio Ballester, PhD</last_name>
    <email>rballester@ibecbarcelona.eu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Addictions Unit. Psychiatry and Psychology Service. Institut Clínic de Neurociències (ICN). Hospital Clínic de Barcelona. IDIBAPS</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Clara Oliveras Salvà, Dr</last_name>
      <phone>34932275400</phone>
      <phone_ext>4210</phone_ext>
      <email>coliveras@clinic.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitat Pompeu Fabra</investigator_affiliation>
    <investigator_full_name>Paul Verschure</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>alcohol-related brain damage</keyword>
  <keyword>depression</keyword>
  <keyword>attention</keyword>
  <keyword>eeg</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Alcohol-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>For the moment IDP is shared between the involved investigators at Hospital Clínic de Barcelona and IBEC.</ipd_description>
  </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/NCT03826238
org study id: REHABOH-VG
nct id: NCT03826238
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilot study where 10 alcohol-related brain damage (ARBD) patients will undergo a
      30-minutes-long cognitive assessment session using the Validation Gate task to evaluate
      usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients
      will also be recorded and compared to the ones of age-matched healthy people in order to
      preliminary explore the existence of possible EEG biomarkers of ARBD.
Much of the burden of disease related to harmful alcohol use is due to the persistent effects
      of alcohol on central nervous system. The concept of alcohol-related brain damage (ARBD) is
      important in the Addiction Psychiatry field. ARBD is a spectrum of disorders. Besides most
      severe forms, 50-70% of patients with alcohol use disorder suffer some kind of cognitive
      impairment, being mild to moderate cognitive impairment the most frequent disorders, and
      often the most difficult to detect. In alcoholic patients, greater cognitive impairment has
      been associated with less treatment compliance and fewer days of abstinence. Considering its
      impact, cognitive screening should be enhanced.

      Recently, standard assessments have been augmented with new interactive technology. The work
      group of the Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), part
      of Institute for Bioengineering of Catalonia (IBEC), developed a virtual assessment of
      cognitive function, called the Validation Gate task, which evaluates sustained attention,
      working memory and executive functioning. This tool has been used so far in chronic stroke
      patients, showing that, in this group, depression symptoms affect performance in this task.

      Similarly to chronic stroke patients, a diffuse harm of several cognitive domains in ARBD is
      observed. In the addiction psychiatry field, the gold standard to evaluate changes in
      cognitive function are still thorough neuropsychological test batteries. But performing
      thorough neuropsychological evaluations on all patients in daily clinical practice is highly
      resource consuming (need of expert neuropsychologists, time consuming). These last years
      scientific community has also been trying to find biomarkers of ARBD in electrophysiological
      tests, with no conclusive results.

      In this pilot study a small number of ARBD patients and healthy people will undergo a single
      30-minutes-long cognitive assessment session using the Validation Gate task to evaluate
      usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients
      will also be recorded and compared to the ones of age-matched healthy controls in order to
      preliminary explore the existence of possible EEG biomarkers of ARBD.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Virtual assessment (Validation Gate task)
time frame: 30 minutes
description: The Validation Gate task, a visual attention task where the patient must detect discontinuities in the moving trajectory of circles on the screen. In this task the following variables will be registered: fast and slow eye saccades as well as conscious detections.
measure: Montreal Cognitive Assessment (MoCA)
time frame: 20 minutes
description: MoCA test is a screening test for cognitive impairment that explores 8 domains: visuospatial/executive ability, naming, memory, attention, language, abstraction, delayed recall, and orientation.
measure: Hamilton Depression Rating Scale
time frame: 10 minutes
description: Evaluation tool of depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The summed score indicates severity (0-7 no depression, > 23 very severe depression)
measure: Resting State and task-dependent EEG
time frame: 40 minutes
description: 6 minutes of EEG data during resting state and 30 minutes of EEG during the Validation Gate taks, will be acquired through the wireless sensor system ENOBIO32 of Starlab. From these recordings the mean spectral energy in the common frequency bands will be obtained as variables to identify signatures of TCD and the theta activity in the different groups.
measure: The alcohol, smoking and substance involvement screening test (ASSIST)
time frame: 10 minutes
description: The ASSIST scale is used to detect substance use and classify risk and severity for each substance. Each question (8 questions) on the ASSIST has a set of responses to choose from, and each response has a numerical score (for instance they can range from 0 for "never" to up to 8 for "daily"). The interviewer simply circles the numerical score that corresponds to the patient's response for each question/substance. At the end of the interview the scores for each substance are added together to produce an ASSIST score for that substance. Low numbers mean low risk, high numbers mean high risk. We are testing only for "Alcohol-Risk", which can have a risk-score from 0 to 31.
measure: Alcohol Use Disorders Identification Test (AUDIT)
time frame: 10 minutes
description: Assessment of alcohol use
arm group label: ARBD and depression
description: 10 patients with ARBD and at least moderate depressive symptoms (MoCA < 26, Hamilton Depression Rating Scale ≥ 17). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.
arm group label: ARBD and no depression
description: 10 patients with ARBD and no clinically relevant depressive symptoms (MoCA < 26, Hamilton Depression Rating Scale < 17). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.
arm group label: Healthy
description: 10 healthy controls (no ARDB, no depression, no cognitive deficit). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.
intervention type: Diagnostic Test
intervention name: Validation Gate task
description: The task is to observe several moving unfilled white circles on a dark background. The circles move in straight paths. Every so often, a randomly selected circle will displace to a point inconsistent with its trajectory, which will look like a "jump". The subjects' task is to press the space bar every time they detect a displacement (e.g. jump). A session consists of 30 minutes, it starts with 2 training blocks which are followed by 2 no-cognitive load blocks and 6 blocks with increasing cognitive load conditions. During the assessment the eye movement as well as the key presses are registered in order to calculate early and late saccades as well as conscious reporting. Resting-state EEG will also be recorded and compared to the ones of age-matched healthy controls. Task-dependent EEG data will be recorded during the Validation Gate task.
arm group label: ARBD and depression
arm group label: ARBD and no depression
arm group label: Healthy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Martina Maier, Ms
phone: 722257096
email: mmaier@ibecbarcelona.eu
last name: Belén Rubio Ballester, PhD
email: rballester@ibecbarcelona.eu
facility: 
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universitat Pompeu Fabra
investigator full name: Paul Verschure
investigator title: Principal Investigator
mesh term: Brain Injuries
mesh term: Alcohol-Related Disorders
sharing ipd: Undecided
ipd description: For the moment IDP is shared between the involved investigators at Hospital Clínic de Barcelona and IBEC.