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NCT07532109 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Boston Children's Hospital.

Not yet
Registry status
70
Enrollment target

NCT07532109: Clinical Trial study, sponsored by Boston Children's Hospital.

NCT07532109 is a clinical trial that has not yet begun recruiting, run by Boston Children's Hospital. The registered enrollment target is 70 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07532109 has not yet begun recruiting, sponsored by Boston Children's Hospital.

NOT YET RECRUITING
Registry status
70 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI)

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2026-07
Est. Completion 2027-06
Boston Children's Hospital

462 total trials

What is known before NCT07532109 opens enrollment

NCT07532109 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) is the first listed.

NCT07532109 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07532109 about?

NCT07532109 is a clinical study titled "Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents". 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. ...

What is the current status of trial NCT07532109?

This trial is currently not yet recruiting. The enrollment target is 70 participants. The study started on 2026-07. Estimated completion is 2027-06.

What interventions are being tested in trial NCT07532109?

The interventions under investigation include: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) (OTHER).

Who is sponsoring clinical trial NCT07532109?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT07532109, the US trial registry maintained by the National Library of Medicine. NCT07532109 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.