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

Part of paid clinical trials in Needham, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07532109
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Vestibular Migraine

Eligibility Criteria

Sex
ALL
Age
10 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Adolescents without Vestibular Migraine of Childhood (Control)
    Adolescents aged 10-20 years old who do not have any history of dizziness and/or migraines.

Primary Outcome Measure

Vestibular Migraine Patient Assessment Tool & Handicap Inventory (VM-PATHI) [ Time Frame: 8 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Boston Children's Hospital at NeedhamNeedhamMassachusetts02494
Jacob R Brodsky, MD
781-216-2849
Kyle K Pandiscio, BS
Boston Children's Hospital at WalthamWalthamMassachusetts02453
Jacob R Brodsky, MD
781-216-2849
Kyle K Pandiscio, BS
Boston Children's Hospital at WeymouthWeymouthMassachusetts02189
Jacob R Brodsky, MD
781-216-2849
Kyle K Pandiscio, BS

Find similar trials in Needham, MA

Related Studies