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.
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
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).
- Conditions
- Vestibular Migraine
- 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 group | Role | What 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.
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)
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
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
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
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.
- First posted15 Apr 2026
- Study startDec 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Brodsky, Boston Children's Hospital
- Investigators
- Jacob R Brodsky, MD, Principal investigator, Boston Children's Hospital
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 26931289Varni 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 10024117Gardi 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 39474873Sharon 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 32176141Kroner-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 20346716Brodsky 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 26521123van 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 33386837Brodsky 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
- ClinicalTrials.gov ID
- NCT07532109
- Acronym / sponsor ID
- IRB-P00054141
- Conditions
- Vestibular Migraine
- Keywords
- vestibular migraine, pediatric dizziness, pediatric migraine, questionnaire, inventory, VM-PATHI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Vestibular Migraine of Childhood (Experimental) | – | Other: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)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. |
| Adolescents without Vestibular Migraine of Childhood (Control) | – | Other: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)Adolescents aged 10-20 years old who do not have any history of dizziness and/or migraines. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Adolescents with Vestibular Migraine of Childhood (Experimental), Adolescents without Vestibular Migraine of Childhood (Control) |
Primary outcome
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.
4 secondary outcomes
Dizziness Handicap Inventory - Children & Adolescents (DHI-CA)
Time frame: 8 months
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 8 months
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure
Time frame: 8 months
Global Rating of Change (GroC) Questionnaire
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 26931289Schalet 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.
- Background: PubMed 10024117Varni 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.
- Background: PubMed 39474873Gardi 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.
- Background: PubMed 32176141Sharon 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.
- Background: PubMed 20346716Kroner-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.
- Background: PubMed 26521123Brodsky 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.
- Background: PubMed 33386837van 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.
- Background: PubMed 31689154Brodsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob R Brodsky, MD principal investigator
Boston Children's Hospital
3 sites in 1 country: see every site and its status.
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.