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

• ClinicalTrials.gov Identifier: NCT04432116
• Recruitment Status: Not yet recruiting
• First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Bipolar Disorder	Behavioral: virtual reality 1; Behavioral: virtual reality 2	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: All interventions are applied to each participant
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: EEG and Behavioural Correlates of Virtual Reality Treatment of Environmental Zeitgebers in Schizophrenia and Bipolar Disorder
• Estimated Study Start Date: September 2020
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: virtual reality 1; the subject is in a virtual room and is asked to emit a retrospective time duration judgement at the end of the session	Behavioral: virtual reality 1; 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
Experimental: virtual reality 2; 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	Behavioral: virtual reality 2; 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; Other Name: virtual reality 3
Experimental: virtual reality 3; 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	Behavioral: virtual reality 2; 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; Other Name: virtual reality 3

Outcome Measures

Primary Outcome Measures :

1. EEG index of time expectation [ Time Frame: through study completion, an average of 2 years ]
   beta oscillations recorded with EEG during the waiting period

Secondary Outcome Measures :

1. retrospective duration [ Time Frame: through study completion, an average of 2 years ]
   Retrospective duration judgement

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT04432116
• Other Study ID Numbers: C19-48
• First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Bipolar Disorder; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders