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Résztvevőt keres itt: FranciaországFázis nélkül

Time and Virtual Reality in Schizophrenia and Bipolar Disorder

A legfontosabb adatok

Hol
Strasbourg (Franciaország)A helyszín megnézése

AI-kivonat: kiket keres a vizsgálat

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat skizofréniával vagy bipoláris zavarral élő felnőtteket és egészséges önkénteseket keres. Mindenki virtuális valóságos időfeladatokat old meg, miközben az agyi aktivitását mérik.

Életkor
18 és 60 év között
Nem
Férfiak és nők is részt vehetnek.
A betegség stádiuma
A betegeknek meg kell felelniük a DSM V szerinti skizofrénia vagy bipoláris zavar diagnózisának. Az összefoglaló szerint a betegek állapota stabil, de krónikus.
Korábbi kezelés
A betegeket neuroleptikummal kell kezelni, parkinson-ellenes szerrel vagy antidepresszánssal együtt vagy nélküle. A benzodiazepint szedő betegek nem vehetnek részt. Az egészséges önkéntesek nem szedhetnek folyamatosan pszichotróp gyógyszert.

A részvétel fő kizáró okai

  • Szerhasználati zavar
  • Benzodiazepin, kannabisz vagy hallucinogén szerek közelmúltbeli használata
  • Neurológiai betegség vagy annak következménye
  • ADHD vagy borderline személyiségzavar
  • Terhes, szülő vagy szoptató nők

Gépi kiolvasás: 2026. november 12.

Neked szólhat?

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 60 év között vagy?

Forrás: NCT04432116: ki vehet részt

Helyszínek itt: Franciaország

  • Services de Psychiatrie I et II - Pôle de Psychiatrie CHRU StrasbourgStrasbourg, FranciaországContact: Dr Anne GIERSCHRésztvevőt keres

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

A vizsgálat adatai

Ki végzi
Institut National de la Santé Et de la Recherche Médicale, France
Azonosító
NCT04432116
A regiszteradat frissítve
2026. március 11.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: - 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).

Kizáró feltételek: 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); 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; Substance Use Disorders (as defined by DSM-V); 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); A neurological pathology or sequelae; Person deprived of liberty or under the safeguard of justice; Pregnant, parturient or breastfeeding women.

ClinicalTrials.gov NCT04432116