SchizophreniaVirtualTimesNCT04432116
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
A study testing virtual reality 1 and virtual reality 2 in people with Schizophrenia and Bipolar Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- virtual reality 1 and virtual reality 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 2021to 12 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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.
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- 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).
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Services de Psychiatrie I et II - Pôle de Psychiatrie CHRU Strasbourg
Strasbourg, 67091
Dr Anne GIERSCH, +33388116471, anne.giersch@inserm.fr
About this study
Official title: EEG and Behavioural Correlates of Virtual Reality Treatment of Environmental Zeitgebers in Schizophrenia and Bipolar Disorder
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
- Being tested
- virtual reality 1, virtual reality 2
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality 1Behavioural
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 2Behavioural
Also called virtual reality 3
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: virtual reality 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG index of time expectation
beta oscillations recorded with EEG during the waiting period
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
retrospective duration
Retrospective duration judgement
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start12 Aug 2021
- Primary completion12 May 2027 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All interventions are applied to each participant
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432116
- Sponsor's protocol ID
- C19-48
- Acronym
- VirtualTimes
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG and Behavioural Correlates of Virtual Reality Treatment of Environmental Zeitgebers in Schizophrenia and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04432116
- Acronym / sponsor ID
- VirtualTimes / C19-48
- Conditions
- Schizophrenia, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- All interventions are applied to each participant
| Arm | Type | Receives |
|---|---|---|
| virtual reality 1 | Experimental | Behavioral: virtual reality 1the subject is in a virtual room and is asked to emit a retrospective time duration judgement at the end of the session |
| virtual reality 2 | Experimental | Behavioral: virtual reality 2the 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 |
| virtual reality 3 | Experimental | Behavioral: virtual reality 2the 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- - 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality 1the 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 | Behavioural | virtual reality 1 |
| virtual reality 2Also: virtual reality 3Subjects 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 | Behavioural | virtual reality 2, virtual reality 3 |
Primary outcome
EEG index of time expectation
Time frame: through study completion, an average of 2 years
beta oscillations recorded with EEG during the waiting period
1 secondary outcome
retrospective duration
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality 1 and virtual reality 2 in people with Schizophrenia and Bipolar Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GIERSCH GIERSCH, Dr (33388116471, anne.giersch@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG index of time expectation (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.