Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Vestibular Migraine Patient Assessment Tool and 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.7 This inventory has been validated in adult patients with VM.

Первичные конечные точки

• Vestibular Migraine Patient Assessment Tool & Handicap Inventory (VM-PATHI) [Срок оценки: 8 months]

Вторичные конечные точки (4)

• Dizziness Handicap Inventory - Children & Adolescents (DHI-CA) [Срок оценки: 8 months]
• Pediatric Quality of Life Inventory (PedsQL) [Срок оценки: 8 months]
• Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure [Срок оценки: 8 months]
• Global Rating of Change (GroC) Questionnaire [Срок оценки: 8 months]

Критерии участия

Experimental Patient Inclusion Criteria:

• Patients aged 10-20 years old.
• Patients meeting the 2021 Bárány Society criteria for definite vestibular migraine of childhood (dVMC) or probable vestibular migraine of childhood (pVMC).

Experimental Patient Exclusion Criteria:

• Patients who do not meet the 2021 Bárány Society criteria for definite vestibular migraine of childhood (dVMC) or probable vestibular migraine of childhood (pVMC).
• Non-English language preference patients.

Control Patient Inclusion Criteria:

• Patients aged 10-20 years old.
• Patients who do not have a history of dizziness and/or migraines.

Control Patient Exclusion Criteria:

• Patients who have a history of dizziness and/or migraines.
• Non-English language preference patients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 3 центра

• Boston Children's Hospital at Needham — Needham
• Boston Children's Hospital at Waltham — Waltham
• Boston Children's Hospital at Weymouth — Weymouth

Публикации

• 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. PMID 26931289
• 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. PMID 10024117
• 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. PMID 39474873
• 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. PMID 32176141
• 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. PMID 20346716
• 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. PMID 26521123
• 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: 10.3 PMID 33386837
• 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. PMID 31689154

Идентификаторы

NCT: NCT07532109 · IRB-P00054141

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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