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

April 9, 2026 updated by: Jacob Brodsky, Boston Children's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular Migraine Patient Assessment Tool & Handicap Inventory (VM-PATHI)
Time Frame: 8 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory - Children & Adolescents (DHI-CA)
Time Frame: 8 months
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.
8 months
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 8 months
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
Time Frame: 8 months
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
Time Frame: 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Jacob R Brodsky, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-P00054141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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