Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Nystagmus response (peak slow phase velocity)
研究概览
简要总结
This study aims to determine if individuals with schizophrenia have greater reactivity to vestibular stimulation than healthy controls. The physiological response of vestibular stimulation will be assessed with electronystagmography, which provides a measure of the intensity of the nystagmus via PSPV. Positive results would suggest greater vestibular system reactivity to vestibular stimulation may be a biomarker of schizophrenia. Pathophysiologically, increased vestibular reactivity to vestibular stimulation may reflect abnormal vestibular function or impaired central suppression of the vestibular ocular reflex.
详细描述
In schizophrenia, there is no conclusive link between psychopathology and vestibular dysfunction and we are not aware of any data that exists on the range of responses to caloric vestibular stimulation (CVS) in persons with schizophrenia. Initial data from another CVS study from our group suggests individuals with schizophrenia have greater reactivity to body temperature (37°C) CVS, as measured by the peak slow phase velocity of the resulting nystagmus (PSPV), than would be expected from individuals without schizophrenia versus healthy participants. Intriguingly, CVS at 37°C should not theoretically produce a significant vestibulocular reflex response due to the stimulus' approximation to body temperature. Hence, the primary aim of this study is to determine if individuals with schizophrenia will have greater vestibular reactivity, as measured by nystagmus PSPV, to CVS in comparison with healthy participants. The secondary aim is to assess illness awareness pre and post CVS administration in attempts to replicate our previous observation. A total of 20 patients with schizophrenia and 20 healthy control participants will be recruited. All participants will receive three conditions bilaterally: (1) body temperature (37°C) vestibular stimulation; (2) warm CVS (44°C), and (3) cold CVS (30°C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will be blinded to the order of experimental conditions, as well as the person conducting specific ratings assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Schizophrenia group:
- •Male or female inpatients or outpatients age ≥18
- •Having a DSM-5 diagnosis of schizophrenia or schizoaffective disorder
- •Voluntary and capable of consenting to participation in the research study
- •Fluent in English
- •Inclusion Criteria for Healthy Controls group:
- •Male or female and age ≥18
- •Voluntary and capable of consenting to participation in the research study
- •Fluent in English
- •Absence of history of psychiatric illness using the Mini-International Neuropsychiatric Interview (MINI)
排除标准
- •for all participants:
- •Serious unstable medical illness or any concomitant major medical or neurological illness
- •Acute suicidal and/or homicidal ideation
- •Formal thought disorder rating of over 2 on the Scale for Assessment of Positive Symptoms (SAPS) [patients only]
- •DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study
- •Pregnant women
- •Positive urine drug screen
- •History of external or middle ear pathology
- •History or signs of middle ear surgery (e.g. Tympanoplasty, mastoidectomy)
- •Signs of active ear disease
研究组 & 干预措施
Left body temperature VS
Left body temperature (37°C) vestibular stimulation
干预措施: Left body temperature VS (Procedure)
Right body temperature VS
Right body temperature (37°C) vestibular stimulation
干预措施: Right body temperature VS (Procedure)
Left warm CVS
Left warm (44°C) caloric vestibular stimulation
干预措施: Left warm CVS (Procedure)
Right warm CVS
Right warm (44°C) caloric vestibular stimulation
干预措施: Right warm CVS (Procedure)
Left cold CVS
Left cold (30°C) caloric vestibular stimulation
干预措施: Left cold CVS (Procedure)
Right cold CVS
Right cold (30°C) caloric vestibular stimulation
干预措施: Right cold CVS (Procedure)
结局指标
主要结局
Nystagmus response (peak slow phase velocity)
时间窗: Between 30 and 60 sec after each CVS condition
Nystagmus response will be measured at between thirty and 60 seconds post irrigations, looking for the highest velocities.
次要结局
- Illness awareness(Before CVS session and10 min after CVS session)
研究者
Philip Gerretsen
Principal Investigator
Centre for Addiction and Mental Health