<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/NCT04432116</url>
  </required_header>
  <id_info>
    <org_study_id>C19-48</org_study_id>
    <nct_id>NCT04432116</nct_id>
  </id_info>
  <brief_title>Time and Virtual Reality in Schizophrenia and Bipolar Disorder</brief_title>
  <acronym>VirtualTimes</acronym>
  <official_title>EEG and Behavioural Correlates of Virtual Reality Treatment of Environmental Zeitgebers in Schizophrenia and Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients with bipolar disorders report an acceleration or slowing of time flow, and patients&#xD;
      with schizophrenic spectrum disorders a time fragmentation. These disorders would be linked&#xD;
      to disorders of the sense of self. Assessing these time-related disorders could help to&#xD;
      better predict psychotic conversion in vulnerable subjects. In this protocol, the&#xD;
      investigators wish to develop playful methods for the evaluation of alterations in the&#xD;
      passage of time, based on the use of virtual reality. The protocol will be tested in&#xD;
      stabilized but chronic bipolar or schizophrenic patients, vs. healthy subjects matched on&#xD;
      age, sex, and study level. The protocol will include two experimental sessions. It will begin&#xD;
      with a waiting room-like session, at the end of which the subject will be asked to&#xD;
      retrospectively estimate the time that will have passed. The games that will follow will all&#xD;
      be based on the principle of temporal waiting. A first signal will indicate the start of the&#xD;
      trial, and a target will be presented at varying times after this first signal. The later the&#xD;
      target is presented, the more the subject expects and prepare for the target, and the faster&#xD;
      he or she is. This time delay is measured by the subject's response (response time, error&#xD;
      rate, eye fixation), but also by electrical signals measured by electroencephalography (EEG).&#xD;
      The two experimental sessions will include several temporal manipulations during these tasks,&#xD;
      intended to highlight alterations in the time flow in patients compared to controls. In one&#xD;
      of the sessions, a starfield will be presented and the speed of the stars in the starfield&#xD;
      will be manipulated, as a proxy for the speed of the environment. In one condition, the speed&#xD;
      of the object will be average, and in the other the speed will be self-adjusted by the&#xD;
      subject. In a control condition, the speed of the object will be zero. In the other&#xD;
      experimental session, distractors will be presented during the waiting phase of the target.&#xD;
      They will be presented either simultaneously or asynchronously. In one control condition the&#xD;
      distractors will be absent. In both sessions it will be examined how the behavioral and EEG&#xD;
      cues are affected by the manipulations. A double dissociation is expected, with greater&#xD;
      disturbance in patients with bipolar disorder when standard movement is used, whereas&#xD;
      patients with schizophrenia should be disturbed mainly when asynchronous distractors are&#xD;
      presented.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Crossover Assignment</intervention_model>
    <intervention_model_description>All interventions are applied to each participant</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG index of time expectation</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>beta oscillations recorded with EEG during the waiting period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>retrospective duration</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Retrospective duration judgement</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>virtual reality 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subject is in a virtual room and is asked to emit a retrospective time duration judgement at the end of the session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>virtual reality 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subject is in a virtual environment mimicking a space ship. The subject is asked to detect targets as fast as possible while the background of the virtual environment is a starfield with standard speed vs. self-determined speed vs. static stars</description>
  </arm_group>
  <arm_group>
    <arm_group_label>virtual reality 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the subject is in a virtual environment mimicking a space ship. The subject is asked to detect targets as fast as possible.Asynchronous distracters vs. synchronous distracters, vs no distracters are displayed while the subjects wait for the target</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>virtual reality 1</intervention_name>
    <description>the subject is in a virtual waiting room, there is no other intervention. The principle of this intervention is to make the subject wait with as little interfering events as possible</description>
    <arm_group_label>virtual reality 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>virtual reality 2</intervention_name>
    <description>Subjects are in a virtual environment mimicking a space ship. On the screen there is a red light and subjects wait for this red light to become green. They press on a pad each time the red light becomes green</description>
    <arm_group_label>virtual reality 2</arm_group_label>
    <arm_group_label>virtual reality 3</arm_group_label>
    <other_name>virtual reality 3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Participant, male or female, between 18 and 60 years old&#xD;
&#xD;
          -  Subject affiliated to a social health insurance scheme (beneficiary or entitled&#xD;
             person)&#xD;
&#xD;
          -  Subject who has dated and signed an informed consent form&#xD;
&#xD;
          -  For a woman of childbearing age, negative pregnancy test and effective contraception&#xD;
             throughout the study&#xD;
&#xD;
          -  A patient under guardianship, whose guardian has dated and signed a consent, as well&#xD;
             as the patient if able.&#xD;
&#xD;
          -  A patient under guardianship, whose consent has been obtained, if necessary, by the&#xD;
             guardian or with the assistance of the guardian, prior to the commencement of any&#xD;
             trial-related procedures.&#xD;
&#xD;
        Patients only:&#xD;
&#xD;
          -  Patients with psychotic disorders (schizophrenia-like): Patients with diagnostic&#xD;
             criteria for schizophrenia as defined by the DSM V (American Psychiatric Association,&#xD;
             2015).&#xD;
&#xD;
          -  Patients with Bipolar Disorder: A patient with diagnostic criteria for bipolar&#xD;
             disorder as defined by the DSM V (American Psychiatric Association, 2015).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substance Use Disorders (as defined by DSM-V)&#xD;
&#xD;
          -  Intake of benzodiazepines (in the period before inclusion, for a duration equivalent&#xD;
             to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or&#xD;
             hallucinogenic substances (in the period before inclusion, for a duration equivalent&#xD;
             to 5 half-lives of the product).&#xD;
&#xD;
          -  A neurological pathology or sequelae&#xD;
&#xD;
          -  Attention Deficit Hyperactivity Disorder (ADHD)&#xD;
&#xD;
          -  Borderline personality disorder&#xD;
&#xD;
          -  Disabling sensory impairment, including visual acuity (corrected, if applicable) &lt; 0.8&#xD;
             (due to the use of visual aids) (Freiburg Vision Test, Bach 1996)&#xD;
&#xD;
          -  Person deprived of liberty or under the safeguard of justice&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding women&#xD;
&#xD;
          -  Subject in a period of exclusion defined by another clinical study.&#xD;
&#xD;
        Healthy volunteers only:&#xD;
&#xD;
        History of major neurological or psychiatric illness with ongoing psychotropic medication&#xD;
        (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine or hypnotic).&#xD;
&#xD;
        Patients only:&#xD;
&#xD;
        Only patients treated with neuroleptics, whether or not combined with an anti-parkinsonian&#xD;
        corrector or anti-depressant, will be included. Patients taking benzodiazepines will be&#xD;
        excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT04432116
org study id: C19-48
nct id: NCT04432116
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with bipolar disorders report an acceleration or slowing of time flow, and patients
      with schizophrenic spectrum disorders a time fragmentation. These disorders would be linked
      to disorders of the sense of self. Assessing these time-related disorders could help to
      better predict psychotic conversion in vulnerable subjects. In this protocol, the
      investigators wish to develop playful methods for the evaluation of alterations in the
      passage of time, based on the use of virtual reality. The protocol will be tested in
      stabilized but chronic bipolar or schizophrenic patients, vs. healthy subjects matched on
      age, sex, and study level. The protocol will include two experimental sessions. It will begin
      with a waiting room-like session, at the end of which the subject will be asked to
      retrospectively estimate the time that will have passed. The games that will follow will all
      be based on the principle of temporal waiting. A first signal will indicate the start of the
      trial, and a target will be presented at varying times after this first signal. The later the
      target is presented, the more the subject expects and prepare for the target, and the faster
      he or she is. This time delay is measured by the subject's response (response time, error
      rate, eye fixation), but also by electrical signals measured by electroencephalography (EEG).
      The two experimental sessions will include several temporal manipulations during these tasks,
      intended to highlight alterations in the time flow in patients compared to controls. In one
      of the sessions, a starfield will be presented and the speed of the stars in the starfield
      will be manipulated, as a proxy for the speed of the environment. In one condition, the speed
      of the object will be average, and in the other the speed will be self-adjusted by the
      subject. In a control condition, the speed of the object will be zero. In the other
      experimental session, distractors will be presented during the waiting phase of the target.
      They will be presented either simultaneously or asynchronously. In one control condition the
      distractors will be absent. In both sessions it will be examined how the behavioral and EEG
      cues are affected by the manipulations. A double dissociation is expected, with greater
      disturbance in patients with bipolar disorder when standard movement is used, whereas
      patients with schizophrenia should be disturbed mainly when asynchronous distractors are
      presented.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: All interventions are applied to each participant
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: EEG index of time expectation
time frame: through study completion, an average of 2 years
description: beta oscillations recorded with EEG during the waiting period
measure: retrospective duration
time frame: through study completion, an average of 2 years
description: Retrospective duration judgement
arm group label: virtual reality 1
arm group type: Experimental
description: the subject is in a virtual room and is asked to emit a retrospective time duration judgement at the end of the session
arm group label: virtual reality 2
arm group type: Experimental
description: the subject is in a virtual environment mimicking a space ship. The subject is asked to detect targets as fast as possible while the background of the virtual environment is a starfield with standard speed vs. self-determined speed vs. static stars
arm group label: virtual reality 3
arm group type: Experimental
description: the subject is in a virtual environment mimicking a space ship. The subject is asked to detect targets as fast as possible.Asynchronous distracters vs. synchronous distracters, vs no distracters are displayed while the subjects wait for the target
intervention type: Behavioral
intervention name: virtual reality 1
description: the subject is in a virtual waiting room, there is no other intervention. The principle of this intervention is to make the subject wait with as little interfering events as possible
arm group label: virtual reality 1
intervention type: Behavioral
intervention name: virtual reality 2
description: Subjects are in a virtual environment mimicking a space ship. On the screen there is a red light and subjects wait for this red light to become green. They press on a pad each time the red light becomes green
arm group label: virtual reality 2
arm group label: virtual reality 3
other name: virtual reality 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Bipolar Disorder