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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-20
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Patients aged 10-20 years old.

Patients who do not have a history of dizziness and/or migraines.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Adolescents with Vestibular Migraine of Childhood (Experimental)1 intervention
Group B: Adolescents without Vestibular Migraine of Childhood (Control)1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
8 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
8 months

Other outcomes

Sponsors and contacts

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