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临床试验/NCT03979677
NCT03979677已完成不适用

Effects of Lifestyle Modification on Vestibular Migraine

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年10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
41
试验地点
2
主要终点
Headache Disability Inventory (HDI)

研究概览

简要总结

Vestibular migraine was recently addressed by the International Headache Society (IHS) as separate from other types of migraine. Vestibular migraine is one of the most common causes of vertigo attacks, affecting 1-5% of people. People with vestibular migraine have lower quality of life compared to others and some are completely debilitated by their symptoms. Symptoms include vertigo, nausea, head motion-induced dizziness, unsteadiness, balance problems, and lightheadedness. Most reports of vestibular migraine management have focused on treatment with medications; however, recommendations also include some form of lifestyle modification. Lifestyle modifications like avoidance of certain foods, improving sleep, exercising, etc. have all been reported to help migraine in general, but there are no reports on the effects of lifestyle modification on vestibular migraine as defined by IHS. It is important to investigate the effects of lifestyle modifications on vestibular migraine because the underlying causes of vestibular migraine are unclear. So, it is also unclear if lifestyle modifications are effective for vestibular migraine. Many investigations of lifestyle modification on migraine include a single modification like diet, weight loss, or sleep. Our modifications include food triggers, restful sleep, exercise, and eating regularity. We hypothesize comprehensive lifestyle modifications will improve symptoms of vestibular migraine. We will measure how people feel dizziness and headache activity is affecting their lives before and after our intervention. This project is important because vestibular migraine is reported to be the one of the most common causes of vertigo and interventions useful for other migraine types may not be effective for vestibular migraine. If we demonstrate improvement with comprehensive lifestyle modifications, we will continue the line of investigation with randomized, controlled studies. This work furthers our goal of helping the many people impacted by vestibular migraine.

详细描述

Significance Dizziness is a frequently reported symptom encountered by healthcare providers, affecting 20-30% of the general population [9, 10]. Vestibular migraine (VM) is one of the more common causes of dizziness, including rotational vertigo, and is reported to be the diagnosis in 11.4% of patients presenting to specialized dizziness centers [11]. Prevalence ranges between 4.3 - 29.3% depending on diagnostic criteria and population [1]. Clearly, VM affects a large segment of the population presenting with dizziness. It is for this reason that diagnostic criteria for VM were included in the appendix of the beta version of the International Classification of Headache Disorders - 3 (ICHD-3β) [5].

Dizziness Common symptoms with VM include rotary vertigo, positional vertigo, sensitivity to motion, unsteadiness, imbalance, and lightheadedness, among others [1, 2]. These types of symptoms can be debilitating. A recent investigation indicated that nearly 70% of patients with VM rated their symptoms as having a moderate to severe impact on health-related quality of life [3]. The authors used the Dizziness Handicap Inventory (DHI) as a disease-specific subjective measure of health-related quality of life [4].

Headache As one might expect with a form of migraine, headache is common with VM and is included as one of the diagnostic criteria found in ICHD-3β. However, the actual criterion is 50% of episodes associated with at least one of the following: headache, photophobia/phonophobia, or visual aura [5]. This is in keeping with the finding that only about 50% of patients with VM report both headache and dizziness at the same time [12]. It is often the case that the headache is temporally distinct.

Pharmacologic Treatment Treatment of VM has focused primarily on pharmacologic intervention [2, 15]. This is based on the use of this type of intervention for other migraine with and without aura rather than the results of randomized controlled studies in patients with VM [1, 2]. One randomized controlled study found that 38% of patients with VM benefitted from zolmitriptan compared to only 22% benefit in the control group given a placebo [16]. This study only had 8 experimental and 9 control participants. Other investigators have reported 57.6% complete reduction in attack frequency with prophylactic use of various types of medication including propranolol, clonazepam, flunarizine, metoprolol, or amitriptyline [17]. Mikulec et al. found reduction in symptoms for 25% of patients using topiramate and a reduction of symptoms in 46% of patients with nortriptyline [18]. Interestingly, they stated 14% of their patients reported reduced symptoms after eliminating caffeine only from their diets. It is interesting that protocols incorporating some type of lifestyle modification along with pharmacologic intervention seem to report relatively higher overall rates of success, 72% for Reploeg and Goebel [19] and 86-92% for Johnson [20].

Lifestyle Modifications as Treatment We find it noteworthy there was an effect of simple elimination of caffeine reported by Mikulec et al. [18]. As stated above, some investigators included dietary modifications along with pharmacologic intervention. Reploeg and Goebel reported 16% of their patients had complete or well-controlled resolution of their symptoms by dietary modifications alone [19]. They also report the improvement was realized in less than four weeks compared to much longer for patients who went on to need intervention with medication. Although only two investigations specifically reported on dietary triggers alone in VM management, dietary considerations, along with other lifestyle modifications continue to be recommended in published reports of treatment of VM [1, 2]. This is because it is well-known there are various triggers for migraine in general and the assumption is this is also true for VM. Orr [6] provides a thorough review of the effects of diet interventions on migraine in general. For diets attempting to eliminate triggering food/drink, the results suggest significant reduction of migraine symptoms in a range of 63-93% of participants. The results of diet modification alone are at least as compelling compared to the results reported for many types of medication. Restful sleep is another factor that seems to improve symptoms of migraine. Smitherman et al. [8] used cognitive behavioral therapy to treat insomnia, a common comorbid symptom reported in migraineurs. They found a 48.9% reduction of headache frequency for the experimental group compared to the control group (25%) at six weeks follow-up. These authors point out another interesting influence on migraine. Their control group actually did experience reduction in headache frequency even without intervention for insomnia. Smitherman et al. related this to their "sham" control that actually may have helped regulate eating times for these participants. Missing meals or fasting is a trigger in as many as 57% of migraineurs [21]. Dieterich et al., in their review of VM treatment, mention the positive effects of vestibular rehabilitation therapy on reduction of migraine [2]. They point out that physical activity, in general, has some benefit on migraine. So, the assumption is that it is the associated adaptation and substitution that is helpful with VRT. In fact, it could just be increased activity. Varkey et al. [22] note a linear relationship between low physical activity and frequency of migraine in general. By increasing physical activity through exercise, it has been suggested that a 40% reduction in migraine headache frequency can be realized [7]. This has not been studied in VM. In fact, there are no specific investigations on the effects of individual lifestyle modifications, much less comprehensive lifestyle modifications, on VM. Two investigations have some data showing modest improvement with slight modification, not comprehensive lifestyle modifications [18, 19].

研究设计

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

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

  • Adults (18 years and older)
  • Must meet International Classification of Headache Disorders criteria for vestibular migraine
  • Must be able to read and comprehend the English language as instructions are only provided in that language

排除标准

  • Younger than 18 years
  • Do not meet IHCD criteria for vestibular migraine
  • Unable to understand English language instructions

结局指标

主要结局

Headache Disability Inventory (HDI)

时间窗: Change in HDI total score will be determined 60-days post intervention.

This measure assesses disease-specific (headache) health-related quality of life using a 0 - 100 scale with 0 indicative of no impact and 100 indicative of severe maximum impact. We will assess change in HDI score by comparing baseline performance to performance 60-days after intervention.

Dizziness Handicap Inventory (DHI)

时间窗: Change in DHI total score will be determined 60-days post intervention.

This measure assesses disease-specific (dizziness) health-related quality of life using a 0 - 100 scale with 0 indicative of no impact and 100 indicative of severe maximum impact.We will assess change in DHI score by comparing baseline performance to performance 60-days post-intervention.

次要结局

未报告次要终点

研究者

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

Richard A. Roberts, Ph.D.

Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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