Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03979677 |
| Other study ID # |
2019-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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].
In the current project we hypothesize that comprehensive lifestyle modifications chosen to
decrease migraine activity will be effective at reducing symptoms of vestibular migraine.
Innovation Previous studies have shown that pharmacologic intervention can be effective for
management of VM, but participant groups were not homogeneous and results are variable.
Studies incorporating pharmacologic intervention plus diet restrictions also seem effective
but with variable results. Studies of patients with VM that have used isolated dietary
restrictions with no pharmacologic intervention indicate modest improvement. The current
project is innovative in at least two ways. First, we will use a comprehensive lifestyle
modification approach with control of dietary triggers, improvement in restful sleep,
increased physical activity, and eating on a regular daily schedule. All of these management
approaches have shown promise in improving symptoms in patients with migraine in general but
have not been combined into a single intervention in patients with vestibular migraine.
Second, we will have a more homogeneous participant group by using the ICDH3β criteria to
diagnose vestibular migraine. This is a likely source of variability in the other published
work on treatment of vestibular migraine. There was not consensus on these criteria until
more recently. The proposed investigation has the potential to improve the way patients with
VM are managed. It is also possible that our results will help other researchers in their
efforts to determine the cause of VM.
Research Plan We propose to test the hypothesis that comprehensive lifestyle modifications
will improve symptoms of vestibular migraine. Previous investigations using pharmacologic
intervention are variable in terms of results and range from 25-100% control of VM symptoms.
Some of these reports were retrospective and many had a small sample size. Interestingly, the
reports that included both some form of lifestyle modification along with pharmacologic
intervention had less variable results (72-92%). This is interesting because the effects of
lifestyle modification without pharmacologic intervention on migraine, in general, seem
promising (63-93% control with diet; 48.9% control with improved sleep; 40% control with
exercise; and even 25% control with regular eating times). This compares well to the results
with either pharmacologic intervention alone or pharmacologic plus dietary intervention. This
evidence forms the basis for our hypothesis.
Specific Aim. Determine the effects of comprehensive lifestyle modifications on subjective
measures of the impact of vestibular migraine on health-related quality of life.
Hypothesis. Comprehensive lifestyle modifications will improve self-perceived impact of the
symptoms of dizziness and headache in individuals with vestibular migraine.
Rationale There is ample evidence in the literature on treatment of migraine, in general,
that lifestyle modifications can improve patient status. This is true for elimination of
food/drink triggers, improved sleep, improved exercise habits, and consistency with eating
times. Even though lifestyle modifications are sometimes included in guidelines on treatment
of VM, there is only little evidence in the literature and this relates to elimination of
caffeine only or triggering food/drink. Those studies showed modest effects even though the
effects of lifestyle modification on migraine in general are much greater and approach 93%
control of symptoms. We hypothesize that by using a comprehensive lifestyle modification
regimen, there will be a greater improvement in patient outcome than what has been reported
for vestibular migraine with caffeine only or food/drink trigger elimination only which
improved 14-16% of their participants. This hypothesis will be tested by obtaining
pre-treatment and post-treatment measures.
Experimental Approach All patients presenting for evaluation of dizziness and imbalance at
our facility who meet the criteria for vestibular migraine as defined by ICHD-3β will be
offered the opportunity to participate in this investigation. Regarding sample size, this is
a preliminary study. Other investigations of VM intervention have used sample sizes ranging
from 5 participants to 111 participants. We have chosen a sample size of 40 for this
preliminary investigation.
1. Properly consented participants will complete the DHI and the HDI. These pre-treatment
scores will be used as a measure of the effects of vestibular migraine on dizziness and
headache impact on health-related quality of life. Participants will also use a 5-point
Likert scale to rate their agreement with statements about current ingestion of common
migraine triggers, restful sleep, exercise, and regularity of eating schedule.
2. Participants will be instructed in our comprehensive lifestyle modification program.
Information will be presented verbally and in written format for later participant
reference. Participants will be instructed to refrain from all common food/drink
triggers for migraine. Participants will receive information on improving sleep hygiene
to enhance restful sleep. Participants will be encouraged to exercise at the same time
daily. Participants will be counseled to eat at the same times during the day.
3. Participants will be compensated with a $25 gift card at this point in the investigation
(Pending VICTR funding).
4. Participants will commit to the comprehensive lifestyle modification plan for 60-days.
It has been reported that when lifestyle modifications were effective in VM, the
response took less than four weeks. 60-days encompasses that duration but also may allow
for future comparison with pharmacologic studies which need a longer time for an effect.
5. The study endpoint for each participant will be after 60-days on the comprehensive
lifestyle modification plan. At that time, participants will return to the Balance
Disorders Laboratory and complete post-treatment DHI and HDI, as well as their agreement
with the Likert scale statements. Finally, participants will be asked to rate their
perceived compliance with each parameter of the comprehensive lifestyle modification
plan.
7. Participants completing the post-treatment measures will receive another $25 gift card in
compensation (Pending VICTR funding).
