AzTrials
AzTrials

Vestibular MigraineNCT07532109

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

An observational study of Vestibular Migraine, run by Boston Children's Hospital at 3 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Vestibular Migraine
What is being tested?
Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)
How many people
70 participants
Where
3 sitesUnited States
Study dates
Dec 2026to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites
  • Boston Children's Hospital at Needham

    Needham, Massachusetts, 02494

    Jacob R Brodsky, MD, 781-216-2849, jacob.brodsky@childrens.harvard.edu

    Kyle K Pandiscio, BS, kyle.pandiscio@childrens.harvard.edu

  • Boston Children's Hospital at Waltham

    Waltham, Massachusetts, 02453

    Jacob R Brodsky, MD, 781-216-2849, jacob.brodsky@childrens.harvard.edu

    Kyle K Pandiscio, BS, kyle.pandiscio@childrens.harvard.edu

  • Boston Children's Hospital at Weymouth

    Weymouth, Massachusetts, 02189

    Jacob R Brodsky, MD, 781-216-2849, jacob.brodsky@childrens.harvard.edu

    Kyle K Pandiscio, BS, kyle.pandiscio@childrens.harvard.edu

Other trials in United States

About this study

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.

Read more

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.

Read the 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).

Being tested
Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)
Keywords
vestibular migraine, pediatric dizziness, pediatric migraine, questionnaire, inventory, VM-PATHI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07532109
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Other: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 months

Secondary outcomes (4)
  1. 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.

    Measured: 8 months

  2. 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.

    Measured: 8 months

  3. 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.

    Measured: 8 months

  4. 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.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07532109
Sponsor's protocol ID
IRB-P00054141
Status last verified
Apr 2026
First submitted
9 Apr 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.3233/VES-200003.

    PubMed 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.

    PubMed 31689154

Questions about this trial

What is this clinical trial studying?

An observational study of Vestibular Migraine, run by Boston Children's Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacob R Brodsky, MD (781-216-2849, jacob.brodsky@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vestibular Migraine Patient Assessment Tool & Handicap Inventory (VM-PATHI) (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07532109, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in