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Time and Virtual Reality in Schizophrenia and Bipolar Disorder (VirtualTimes)

Primary Purpose

Schizophrenia, Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
virtual reality 1
virtual reality 2
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Participant, male or female, between 18 and 60 years old
  • Subject affiliated to a social health insurance scheme (beneficiary or entitled person)
  • Subject who has dated and signed an informed consent form
  • For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study
  • A patient under guardianship, whose guardian has dated and signed a consent, as well as the patient if able.
  • A patient under guardianship, whose consent has been obtained, if necessary, by the guardian or with the assistance of the guardian, prior to the commencement of any trial-related procedures.

Patients only:

  • Patients with psychotic disorders (schizophrenia-like): Patients with diagnostic criteria for schizophrenia as defined by the DSM V (American Psychiatric Association, 2015).
  • Patients with Bipolar Disorder: A patient with diagnostic criteria for bipolar disorder as defined by the DSM V (American Psychiatric Association, 2015).

Exclusion Criteria:

  • Substance Use Disorders (as defined by DSM-V)
  • Intake of benzodiazepines (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product).
  • A neurological pathology or sequelae
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Borderline personality disorder
  • Disabling sensory impairment, including visual acuity (corrected, if applicable) < 0.8 (due to the use of visual aids) (Freiburg Vision Test, Bach 1996)
  • Person deprived of liberty or under the safeguard of justice
  • Pregnant, parturient or breastfeeding women
  • Subject in a period of exclusion defined by another clinical study.

Healthy volunteers only:

History of major neurological or psychiatric illness with ongoing psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine or hypnotic).

Patients only:

Only patients treated with neuroleptics, whether or not combined with an anti-parkinsonian corrector or anti-depressant, will be included. Patients taking benzodiazepines will be excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    virtual reality 1

    virtual reality 2

    virtual reality 3

    Arm Description

    the subject is in a virtual room and is asked to emit a retrospective time duration judgement at the end of the session

    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

    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

    Outcomes

    Primary Outcome Measures

    EEG index of time expectation
    beta oscillations recorded with EEG during the waiting period

    Secondary Outcome Measures

    retrospective duration
    Retrospective duration judgement

    Full Information

    First Posted
    June 3, 2020
    Last Updated
    June 11, 2020
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04432116
    Brief Title
    Time and Virtual Reality in Schizophrenia and Bipolar Disorder
    Acronym
    VirtualTimes
    Official Title
    EEG and Behavioural Correlates of Virtual Reality Treatment of Environmental Zeitgebers in Schizophrenia and Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Bipolar Disorder

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    All interventions are applied to each participant
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    virtual reality 1
    Arm Type
    Experimental
    Arm 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 Title
    virtual reality 2
    Arm Type
    Experimental
    Arm 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 Title
    virtual reality 3
    Arm Type
    Experimental
    Arm 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(s)
    virtual reality 1
    Intervention 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    virtual reality 2
    Other Intervention Name(s)
    virtual reality 3
    Intervention 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
    Primary Outcome Measure Information:
    Title
    EEG index of time expectation
    Description
    beta oscillations recorded with EEG during the waiting period
    Time Frame
    through study completion, an average of 2 years
    Secondary Outcome Measure Information:
    Title
    retrospective duration
    Description
    Retrospective duration judgement
    Time Frame
    through study completion, an average of 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Participant, male or female, between 18 and 60 years old Subject affiliated to a social health insurance scheme (beneficiary or entitled person) Subject who has dated and signed an informed consent form For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study A patient under guardianship, whose guardian has dated and signed a consent, as well as the patient if able. A patient under guardianship, whose consent has been obtained, if necessary, by the guardian or with the assistance of the guardian, prior to the commencement of any trial-related procedures. Patients only: Patients with psychotic disorders (schizophrenia-like): Patients with diagnostic criteria for schizophrenia as defined by the DSM V (American Psychiatric Association, 2015). Patients with Bipolar Disorder: A patient with diagnostic criteria for bipolar disorder as defined by the DSM V (American Psychiatric Association, 2015). Exclusion Criteria: Substance Use Disorders (as defined by DSM-V) Intake of benzodiazepines (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product). A neurological pathology or sequelae Attention Deficit Hyperactivity Disorder (ADHD) Borderline personality disorder Disabling sensory impairment, including visual acuity (corrected, if applicable) < 0.8 (due to the use of visual aids) (Freiburg Vision Test, Bach 1996) Person deprived of liberty or under the safeguard of justice Pregnant, parturient or breastfeeding women Subject in a period of exclusion defined by another clinical study. Healthy volunteers only: History of major neurological or psychiatric illness with ongoing psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine or hypnotic). Patients only: Only patients treated with neuroleptics, whether or not combined with an anti-parkinsonian corrector or anti-depressant, will be included. Patients taking benzodiazepines will be excluded

    12. IPD Sharing Statement

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    Time and Virtual Reality in Schizophrenia and Bipolar Disorder

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