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临床试验/NCT07000929
NCT07000929已完成不适用

The Use of Videonystagmography With Caloric Testing as an Instrumental Diagnostic Method for Vestibular Migraine

Dr. med. Lukas Becker2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2023年10月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
175
试验地点
2
主要终点
Comparison head impulse test (vHIT)

研究概览

简要总结

In the study, the investigators would like to examine whether there is a difference between patients with vestibular migraine, patients with episodic or chronic migraine and healthy subjects in the examination of videonystagmography, which has been used for many years to differentiate and diagnose vertigo disorders. Accordingly, videonystagmography could also be discussed as an important diagnostic instrument for the diagnosis of the still young disease vestibular migraine.

详细描述

Vestibular migraine is a young disorder that is caught between headache experts and vertigo experts. In 2012, the International Bárány Society for Neurootology and the International Headache Society were able to agree on a uniform definition and terminology for "vestibular migraine" in a jointly formulated consensus paper. A distinction is currently made between "definite" and "probable" vestibular migraine on the basis of the applicable diagnostic criteria. The diagnostic criteria are based on a study from 2001 with 75 patients and a follow-up period of 8 years, in which the diagnosis was confirmed in 84% of cases. At present the diagnostic criterion still requires the exclusion of another possible vestibular or ICHD diagnosis. Vestibular migraine is reported in the literature as the most common cause of spontaneous episodic vertigo attacks in adults and children. A manifestation is basically possible at any age. Despite the frequency of vestibular migraine and the sometimes pronounced level of suffering, the publication density is low and the diagnosis is mainly based on the patient medical history and clinical neurological examination. No specific instrumental diagnostic method or specific biomarkers that confirm or even prove the diagnosis are known. Larger studies with the intention of improving the diagnosis and thus achieving the expected reduction in the postulated high number of unreported cases have not yet been carried out. In the regular examination of patients with vertigo, videonystagmography with caloric testing is already an established and necessary examination procedure that is used to diagnose many different vertigo disorders. In the investigations, patients with confirmed vestibular migraine often show a vestibular hyperexcitability or increased caloric reaction not previously described in the literature. The investigators would like to verify this with this study. The investigators therefore developed the hypothesis of a possible correlation between a certain nystagmus frequency and/or certain speed of the slow phase of the nystagmus and the presence of a vestibular migraine. Comparisons with patients with headache migraine without accompanying vertigo symptoms and with a healthy control group should be carried out to test the hypothesis. First, all patients at the Dizziness Center at University Hospital Essen with diagnosed vestibular migraine without other conditions, except episodic or chronic migraine, were analyzed in the first quarter of 2023. This was followed by the inclusion of patients with episodic or chronic migraine and no vestibular migraine, standardized by age and gender, as well as the inclusion of a healthy control group without migraine headache and without vestibular migraine. Following that the collected data will be analyzed in particular the videonystagmography with caloric testing and the comparison of the groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Group 1: The diagnosis of vestibular migraine is confirmed.
  • Group 2: The diagnosis of episodic or chronic migraine is confirmed. There is no coexisting vestibular migraine.
  • Group 3: healthy subjects without vestibular migraine and episodic or chronic migraine

排除标准

  • Simultaneous presence of another confirmed vertigo disorder
  • A previous hearing loss
  • Simultaneous presence of a chronic disease that affects the sense of balance
  • Taking medication with a central effect that affects the sense of balance
  • An existing eardrum defect or a blocked ear canal due to earwax

研究组 & 干预措施

Vestibular migraine confirmed

Patients who received a diagnosis of vestibular migraine.

干预措施: Videonystagmography (Diagnostic Test)

Episodic or chronic migraine, without vestibular migraine

Patients who received a diagnosis of episodic or chronic migraine without vestibular migraine.

干预措施: Videonystagmography (Diagnostic Test)

Healthy participants

Patients who not received a diagnosis of episodic or chronic migraine nor vestibular migraine.

干预措施: Videonystagmography (Diagnostic Test)

结局指标

主要结局

Comparison head impulse test (vHIT)

时间窗: result of head impulse test at study enrollment, Baseline

Comparison of the mean between the group of patients with vestibular migraine and the patients and healthy participants in the qualitativ analysis of the head impulse test

mean comparison nystagmus frequency

时间窗: Mean of nystagmus frequency at study enrollment, Baseline

Comparison of the mean between the group of patients with vestibular migraine and the patients and healthy participants in the mean nystagmus frequency within 30 seconds

mean comparison GLP (speed of the slow phase) of nystagmus in °/s or sum of °/s

时间窗: Mean of nystagmus GLP at study enrollment, Baseline

Comparison of the mean between the group of patients with vestibular migraine and the patients and healthy participants in the mean GLP of nystagmus in °/s or sum of °/s

次要结局

未报告次要终点

研究者

发起方
Dr. med. Lukas Becker
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Lukas Becker

Principal Investigator

Universitätsklinikum Essen

研究点 (2)

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