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Trial record 1 of 8 for:    lifestyle | Migraine | United States
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Effects of Lifestyle Modification on Vestibular Migraine (LMVM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979677
Recruitment Status : Enrolling by invitation
First Posted : June 7, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Richard A. Roberts, Ph.D., Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Headache Disability Inventory (HDI) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Lifestyle Modification on Vestibular Migraine
Official Title  ICMJE Effects of Lifestyle Modification on Vestibular Migraine
Brief 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.
Detailed 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Eligible participants will receive information on food/beverage triggers to avoid, restful sleep tips, simple exercise tips, and eating regularly at the same time. Participants will return after 60 days and both pre- and post-intervention measures will be obtained.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vestibular Migraine
Intervention  ICMJE Behavioral: Lifestyle Modifications
Written suggestions on common migraine triggering food/beverages to avoid, restful sleep tips, exercise suggestions, and eating set mealtimes will be provided as the intervention.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Younger than 18 years
  • Do not meet IHCD criteria for vestibular migraine
  • Unable to understand English language instructions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979677
Other Study ID Numbers  ICMJE 2019-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard A. Roberts, Ph.D., Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanderbilt University Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP