跳至主要内容
临床试验/NCT07532109
NCT07532109尚未招募不适用

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

Boston Children's Hospital3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
3
主要终点
Vestibular Migraine Patient Assessment Tool & Handicap Inventory (VM-PATHI)

研究概览

简要总结

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.

详细描述

Approximately 1.59 million children in the United States have experienced issues due to dizziness symptoms, yet awareness and appropriate management of dizziness is greatly limited among pediatric providers. 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. Such a measure would be valuable to monitor patients' progress in response to different interventions over time.

Existing validated measures often used to assess vestibular migraine in children, such as the Dizziness Handicap Inventory - Child and Adolescents (DHI-CA) or the Pediatric Migraine Disability Assessment Score (PedMIDAS), can be useful, but only assess specifics aspects VMC, such as dizziness or migraine. They 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. To our knowledge, it is the first validated symptom inventory that is specific to vestibular migraine. 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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) (Other)

Adolescents without Vestibular Migraine of Childhood (Control)

Adolescents aged 10-20 years old who do not have any history of dizziness and/or migraines.

干预措施: Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) (Other)

结局指标

主要结局

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

时间窗: 8 months

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.

次要结局

  • Dizziness Handicap Inventory - Children & Adolescents (DHI-CA)(8 months)
  • Pediatric Quality of Life Inventory (PedsQL)(8 months)
  • Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure(8 months)
  • Global Rating of Change (GroC) Questionnaire(8 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Brodsky

Director, Balance & Vestibular Program

Boston Children's Hospital

研究点 (3)

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