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
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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) — OTHERA 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
- Jacob R Brodsky, MD781-216-2849
- Kyle K Pandiscio, BS781-216-1633
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital at Needham | Needham | Massachusetts | 02494 | Kyle K Pandiscio, BS |
| Boston Children's Hospital at Waltham | Waltham | Massachusetts | 02453 | Kyle K Pandiscio, BS |
| Boston Children's Hospital at Weymouth | Weymouth | Massachusetts | 02189 | Kyle K Pandiscio, BS |
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