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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 20 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a symptom questionnaire called VM-PATHI works well for young people with vestibular migraine, a type of migraine that causes dizziness. It also looks at how much a score must change to show a real change in symptoms. People ages 10–20 with this condition, and those with no history of dizziness or migraines, may join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants: Must be 10–20 years old.
  • Migraine group: Must meet the 2021 Bárány Society guidelines for definite or probable vestibular migraine of childhood.
  • Comparison group: Must have no history of dizziness or migraines.

Who can't join

  • All participants: Cannot join if they prefer a language other than English.
  • Migraine group: Cannot join if they do not meet the required guidelines for vestibular migraine of childhood.
  • Comparison group: Cannot join if they have a history of dizziness or migraines.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

MA