Time and Virtual Reality in Schizophrenia and Bipolar Disorder

NCT04432116 | Recruiting DMC

• 1 other identifier: C19-48
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• EEG index of time expectation

  beta oscillations recorded with EEG during the waiting period

  through study completion, an average of 2 years

Secondary Outcomes (1)

• retrospective duration

  through study completion, an average of 2 years

Study Arms (3)

virtual reality 1

EXPERIMENTAL

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

virtual reality 2

EXPERIMENTAL

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

virtual reality 3

EXPERIMENTAL

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

Interventions

virtual reality 2 BEHAVIORAL

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

Also known as: virtual reality 3

virtual reality 2; virtual reality 3

virtual reality 1 BEHAVIORAL

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

virtual reality 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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).

You may not qualify if:

• Substance Use Disorders (as defined by DSM-V)
• 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
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Services de Psychiatrie I et II - Pôle de Psychiatrie CHRU Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

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

Central Study Contacts

GIERSCH GIERSCH, Dr

CONTACT

33388116471; anne.giersch@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All interventions are applied to each participant

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 16, 2020
• Study Start: August 12, 2021
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): May 12, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (1)