跳至主要内容
临床试验/NCT07057024
NCT07057024进行中(未招募)不适用

Contribution of Virtual Reality Eye Tracking in the Identification of Schizophrenia, Bipolar and Depression

Etablissement Public de Santé Barthélemy Durand2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
2
主要终点
Record dwell time (millisecond) and saccadic parameters (millisecond and degree) using an eye-tracker connected to a virtual reality HMD. Then, compare each measure to identify schizophrenia, bipolar, depression and control group differences.

研究概览

简要总结

Schizophrenia (SCZ), bipolar disorder (BP), and depression (DEP) are systematically associated with a severe impairment of the overall abilities of patients, which precludes them from functioning adequately in daily life. A large body of literature emphasises the importance of identifying specific markers for these pathologies to prevent or anticipate the emergence of new psychopathological symptoms.

As a result, one of the current research challenges is to develop new, faster, and more reliable tools. Eye movements are physiological signs involving brain areas that control cognitive processes. These same processes could be altered in psychiatric disorders, and these alterations could produce many eye movement abnormalities.

The literature highlights some eye movement abnormalities specific to each targeted pathology. However, to our knowledge, no study has compared eye movement abnormalities in a virtual environment projected in a head-mounted display (HMD).

The investigators hypothesised that an eye tracker connected to an HMD could identify specific eye movement abnormalities of SCZ, BP, and DEP. Recording eye movements specific to these pathologies in pseudo-ecological situations could lead to better identification methods.

详细描述

Schizophrenia (SCZ), bipolar disorder (BP), and depression (DEP) are among the most incapacitating pathologies. Specific abnormalities such as characteristics of fixations (stability of the eye) and saccades (movement between one fixation point to an another) are proposed as endophenotypic markers of these diseases, particularly in SCZ and BP.

In SCZ, literature reports as core abnormalities a saccadic pursuit in the Smooth Pursuit Eye Movement (SPEM) and a restricted field of exploration in free-viewing. In BP, fixation times and eye movement velocity during free-viewing differ from those identified in SCZ. When psychotic features are present, BP's pursuit movement is similar to SCZ's. Moreover, eye movement abnormalities are correlated with the presence of manic/hypomanic or depressive symptoms, even in or saccadic paradigms (i.e., anti-saccade or guided memorisation). In DEP, eye movements are significantly different from BP regarding movement velocity, while fixation times are similar in the saccade or free viewing paradigms. In addition, pursuit movements are not saccadic in the SPEM task.

Nevertheless, studies do not necessarily use equipment with the same performance, and eye-tracking technology constantly evolves. Eye-tracking can now be included in Virtual Reality (VR) Head- Mounted Displays, permitting the creation of new pseudo-ecological paradigms.

The investigators hypothesise that abnormalities in eye movements in SCZ, BP, and DEP will be identifiable in VR environments compared to healthy controls, and could differentiate them one from the other.

Participants will be assessed using scales and questionnaires and eye-tracking in VR environments. The data will be analysed using statistical processing to identify significant differences in eye movements between SCZ, BP, and DEP and healthy controls.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For all participants:
  • •Male or female, aged 18 to 60 years
  • •Subject having given their written consent to the study For Schizophrenia participants :
  • •Diagnosis of schizophrenia according to DSM-V criteria and stabilised for at least three months
  • •For bipolar disorder participants :
  • •- Diagnosis of bipolar disorders according to DSM-V criteria and stabilised for at least three months
  • •For depressive disorders participants :
  • •- Diagnosis of depressive disorders according to DSM-V criteria and stabilised for at least three months

排除标准

  • •For all the participants :
  • •Subjects unable to give consent or not volunteering for the study.
  • •Current(s) somatic(s) condition(s)
  • •Specific ophthalmological problems (strabismus, amblyopia) incompatible with the devices stereoscopic (VR headsets)
  • •Head trauma's history with loss of consciousness
  • •Epilepsy history
  • •Intellectual disability
  • •Difficulties in understanding the French language
  • •Current or during the last 6 months of substance abuse or dependence (except tobacco)
  • •Freedom restriction by judicial or administrative decision and/or coercive hospitalisation
  • •Cybersickness history
  • •Pregnancy
  • •For healthy control group :
  • •Current or previous psychiatric disorder
  • •Current psychotropic drug therapy

研究组 & 干预措施

Eye movements in virtual reality record

Experimental

All participants will be assessed in virtual reality environments with eye tracking recording environments and eye tracking recording with a Varjo XR4 HMD.

干预措施: Clinical and eye movements (Other)

结局指标

主要结局

Record dwell time (millisecond) and saccadic parameters (millisecond and degree) using an eye-tracker connected to a virtual reality HMD. Then, compare each measure to identify schizophrenia, bipolar, depression and control group differences.

时间窗: 90 minutes

Comparison of eye-tracking metrics in schizophrenia, bipolar disorder, depression, and control groups using virtual reality.

次要结局

  • Correlations between clinical and psychometric assessment results and eye-tracking metrics recorded in virtual reality(95 minutes)

研究者

发起方
Etablissement Public de Santé Barthélemy Durand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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