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Effects of Lifestyle Modification on Vestibular Migraine (LMVM)

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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

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.

Condition or disease Intervention/treatment Phase
Vestibular Migraine Behavioral: Lifestyle Modifications Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Effects of Lifestyle Modification on Vestibular Migraine
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979677


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center

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Responsible Party: Richard A. Roberts, Ph.D., Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03979677     History of Changes
Other Study ID Numbers: 2019-001
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard A. Roberts, Ph.D., Vanderbilt University Medical Center:
vestibular migraine, dizziness, vertigo
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases