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临床试验/NCT03048370
NCT03048370已完成不适用

Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Gerretsen

Principal Investigator

Centre for Addiction and Mental Health

研究点 (2)

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