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Vestibular migraine (VM) is the most common cause of episodic dizziness in children and adults. Dizziness, especially in conjunction with other migraine symptoms (headache, photophobia, phonophobia, etc.) can profoundly decrease quality of life, so effective treatment of VM is of utmost importance.
Unfortunately, there is sparse research on effective treatment methods for VM, and even less for vestibular migraine of childhood (VMC), for which diagnostic criteria was recently defined by the Bárány Society in 2021. Lifestyle changes are often a large part of the treatment plan, and pharmacological treatment is also common, but their efficacies in treating VMC are less than ideal. In truth, there is yet to be a "gold-standard" medication or other treatment method for VMC.
There is a dire need for structured research on the efficacy of different treatments, both lifestyle and pharmacological, in treating pediatric patients with vestibular migraine. However, in order to conduct this research, a validated inventory to objectively and reliably measure vestibular migraine symptoms in children is required. Existing validated measures often used to assess vestibular migraine in children, do not account for the wide array of other symptoms associated with pediatric vestibular migraine.
The Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) - pronounced "Vempathy" - is a symptom inventory designed by Dr. Jeffrey Sharon and colleagues specifically to assess VM in adults. His group also worked to estimate a minimal clinically important difference (MCID) for the VM-PATHI in adults, finding that a change in VM-PATHI score of 6 points or more likely demonstrates an authentic clinical change in patient condition.
This study aims to validate the VM-PATHI for adolescents with VM and estimate a MCID for the VM-PATHI in adolescent patients with vestibular migraine.
Approximately 1.59 million children in the United States have experienced issues due to dizziness symptoms, yet awareness and appropriate management of dizziness is greatly limited among pediatric providers. Vestibular migraine (VM) is the most common cause of episodic dizziness in children and adults. Dizziness, especially in conjunction with other migraine symptoms (headache, photophobia, phonophobia, etc.) can profoundly decrease quality of life, so effective treatment of VM is of utmost importance.
Unfortunately, there is sparse research on effective treatment methods for VM, and even less for vestibular migraine of childhood (VMC), for which diagnostic criteria was recently defined by the Bárány Society in 2021. Lifestyle changes are often a large part of the treatment plan, and pharmacological treatment is also common, but their efficacies in treating VMC are less than ideal. In truth, there is yet to be a "gold-standard" medication or other treatment method for VMC.
There is a dire need for structured research on the efficacy of different treatments, both lifestyle and pharmacological, in treating pediatric patients with vestibular migraine. However, in order to conduct this research, a validated inventory to objectively and reliably measure vestibular migraine symptoms in children is required. Such a measure would be valuable to monitor patients' progress in response to different interventions over time.
Existing validated measures often used to assess vestibular migraine in children, such as the Dizziness Handicap Inventory - Child and Adolescents (DHI-CA) or the Pediatric Migraine Disability Assessment Score (PedMIDAS), can be useful, but only assess specifics aspects VMC, such as dizziness or migraine. They do not account for the wide array of other symptoms associated with pediatric vestibular migraine.
The Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) - pronounced "Vempathy" - is a symptom inventory designed by Dr. Jeffrey Sharon and colleagues specifically to assess VM in adults. To our knowledge, it is the first validated symptom inventory that is specific to vestibular migraine. His group also worked to estimate a minimal clinically important difference (MCID) for the VM-PATHI in adults, finding that a change in VM-PATHI score of 6 points or more likely demonstrates an authentic clinical change in patient condition.
This study aims to validate the VM-PATHI for adolescents with VM. We hypothesize that it will demonstrate good reliability in adolescents based on the following assessments: (1) Cronbach's α; (2) Convergent validity relative to the DHI-CA, PedsQL quality of life inventory, and PROMIS Anxiety Pediatric Inventory; (3) Discriminant validity compared to an age-matched control group without VM; (4) Test-retest reliability compared to subsequent re-administration of the inventory to the same experimental cohort one week after the initial test administration.
This study also aims to use a global rating of change (GroC) scale to estimate a MCID for the VM-PATHI in adolescent patients with vestibular migraine. We hypothesize that the MCID optimal cut-off score to differentiate adolescents who are responding to treatment vs. those who are not responding to treatment will be similar to that identified in adults (which was a change of 6 points or more).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents with Vestibular Migraine of Childhood (Experimental) | Adolescents aged 10-20 years old who have received a diagnosis of Vestibular Migraine of Childhood (VMC) per the 2021 Barany Society and International Headache Society diagnostic criteria. |
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| Adolescents without Vestibular Migraine of Childhood (Control) | Adolescents aged 10-20 years old who do not have any history of dizziness and/or migraines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) | Other | A 25-item self-reported inventory that specifically quantifies the symptoms associated with VM. It is organized into 6 sections (headache, motion sensitivity, anxiety, cognition, disequilibrium, emotion). Scores for each item range from 0 (no problem) to 4 (problem is as bad as it can be) - minimum score is 0; maximum score is 100. Higher score indicates worse symptoms due to VM.7 This inventory has been validated in adult patients with VM. |
| Measure | Description | Time Frame |
|---|---|---|
| Vestibular Migraine Patient Assessment Tool & Handicap Inventory (VM-PATHI) | A 25-item self-reported inventory that specifically quantifies the symptoms associated with VM. It is organized into 6 sections (headache, motion sensitivity, anxiety, cognition, disequilibrium, emotion). Scores for each item range from 0 (no problem) to 4 (problem is as bad as it can be) - minimum score is 0; maximum score is 100. Higher score indicates worse symptoms due to VM. This inventory has been validated in adult patients with VM. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory - Children & Adolescents (DHI-CA) | A 25-item self-assessment designed to be completed by children/adolescents, that measures the impact of dizziness on daily functioning in the past month. It measures self-perceived handicap due to dizziness in three domains (functional, emotional, physical). Scores for each item are either 0 (no), 2 (sometimes), or 4 (yes) - minimum score is 0; maximum score is 100. Higher score indicates greater perceived disability due to dizziness. |
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Experimental Patient Inclusion Criteria:
Experimental Patient Exclusion Criteria:
Control Patient Inclusion Criteria:
Control Patient Exclusion Criteria:
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Our study population of interest are adolescents (10-20 years old) who meet the criteria for Vestibular Migraine of Childhood per the 2021 Bárány Society diagnostic criteria at our quaternary pediatric vestibular program.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob R Brodsky, MD | Contact | 781-216-2849 | jacob.brodsky@childrens.harvard.edu | |
| Kyle K Pandiscio, BS | Contact | 781-216-1633 | kyle.pandiscio@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacob R Brodsky, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital at Needham | Needham | Massachusetts | 02494 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26931289 | Background | Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27. | |
| 10024117 | Background | Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003. |
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| 8 months |
| Pediatric Quality of Life Inventory (PedsQL) | A 23-item self-reported inventory that measures health-related quality of life in children and adolescents within the past month. It assesses quality of life on 4 multidimensional scales (physical, emotional, social, school). Scores for each item range from 0 (never) to 4 (almost always) and total score is calculated - minimum score is 0; maximum score is 100. Higher score indicates better health-related quality of life. | 8 months |
| Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure | An 8-item self-report measure that screens for the presence of and quantifies the severity of anxiety symptoms in the past 7 days. It is a publicly available system of precise patient-reported health status measures for physical, mental, and social well-being, funded by the National Institute of Health. Scores for each item range from 1 (never) to 5 (almost always) - minimum score is 8; maximum score is 40. Higher score suggests more severe anxiety symptoms. | 8 months |
| Global Rating of Change (GroC) Questionnaire | A simple, one question questionnaire using a 7-point Likert scale that asks about the change in patients' VM symptoms over the past 3 months. Scores include the following: 0 = "very much worse," 1 = "moderately worse," 2 = "a little worse," 3 = "no change," 4 = "a little better," 5 = "moderately better," 6 = "very much better." The GroC will be used to help us determine the minimal clinically important difference (MCID) of VM-PATHI in adolescents. | 8 months |
| Boston Children's Hospital at Waltham | Waltham | Massachusetts | 02453 | United States |
|
| Boston Children's Hospital at Weymouth | Weymouth | Massachusetts | 02189 | United States |
|
| 39474873 | Background | Gardi A, Hum M, Wong D, Allen I, Sharon JD. Minimal Clinically Important Difference of Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI). Otolaryngol Head Neck Surg. 2025 Feb;172(2):623-628. doi: 10.1002/ohn.1035. Epub 2024 Oct 30. |
| 32176141 | Background | Sharon JD, Krauter R, Kirk L, Pasquesi L, Allen IE, Formeister EJ, Michael RL, Levin M. Development and Validation of VM-PATHI: Vestibular Migraine Patient Assessment Tool and Handicap Inventory. Otol Neurotol. 2020 Apr;41(4):e494-e500. doi: 10.1097/MAO.0000000000002561. |
| 20346716 | Background | Kroner-Herwig B, Heinrich M, Vath N. The assessment of disability in children and adolescents with headache: adopting PedMIDAS in an epidemiological study. Eur J Pain. 2010 Oct;14(9):951-8. doi: 10.1016/j.ejpain.2010.02.010. Epub 2010 Mar 25. |
| 26521123 | Background | Brodsky JR, Cusick BA, Zhou G. Evaluation and management of vestibular migraine in children: Experience from a pediatric vestibular clinic. Eur J Paediatr Neurol. 2016 Jan;20(1):85-92. doi: 10.1016/j.ejpn.2015.09.011. Epub 2015 Oct 22. |
| 33386837 | Background | van de Berg R, Widdershoven J, Bisdorff A, Evers S, Wiener-Vacher S, Cushing SL, Mack KJ, Kim JS, Jahn K, Strupp M, Lempert T. Vestibular Migraine of Childhood and Recurrent Vertigo of Childhood: Diagnostic criteria Consensus document of the Committee for the Classification of Vestibular Disorders of the Barany Society and the International Headache Society. J Vestib Res. 2021;31(1):1-9. doi: 10.3233/VES-200003. |
| 31689154 | Background | Brodsky JR, Lipson S, Bhattacharyya N. Prevalence of Pediatric Dizziness and Imbalance in the United States. Otolaryngol Head Neck Surg. 2020 Feb;162(2):241-247. doi: 10.1177/0194599819887375. Epub 2019 Nov 5. |