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

NCT07532109 | Not Yet Recruiting

• 1 other identifier: IRB-P00054141
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Vestibular Migraine

Keywords

vestibular migraine; pediatric dizziness; pediatric migraine; questionnaire; inventory; VM-PATHI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Dizziness Handicap Inventory - Children & Adolescents (DHI-CA)

  8 months

• Pediatric Quality of Life Inventory (PedsQL)

  8 months

• Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure

  8 months

• Global Rating of Change (GroC) Questionnaire

  8 months

Study Arms (2)

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.

Other: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)

Adolescents without Vestibular Migraine of Childhood (Control)

Adolescents aged 10-20 years old who do not have any history of dizziness and/or migraines.

Other: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)

Interventions

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.

Adolescents with Vestibular Migraine of Childhood (Experimental); Adolescents without Vestibular Migraine of Childhood (Control)

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (3)

Boston Children's Hospital at Needham

Needham, Massachusetts, 02494, United States

Location

Boston Children's Hospital at Waltham

Waltham, Massachusetts, 02453, United States

Location

Boston Children's Hospital at Weymouth

Weymouth, Massachusetts, 02189, United States

Location

Related Publications (8)

• 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 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.

  PMID: 10024117 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.

  PMID: 39474873 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.

  PMID: 32176141 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.

  PMID: 20346716 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.

  PMID: 26521123 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.

  PMID: 33386837 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.

  PMID: 31689154 BACKGROUND

Study Officials

• Jacob R Brodsky, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Balance & Vestibular Program

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)