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Non-Pharmacological Treatment of Vestibular Migraine in Children and Adolescent

Primary Purpose

Vestibular Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Lifestyle modifications
Vestibular rehabilitation exercise
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Migraine focused on measuring Children, Adolescent, Non-pharmacological, lifestyle modifications, vestibular rehabilitation therapy

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children and adolescents between 5-18 years Diagnosed with vestibular migraine based on the Diagnostic criteria consensus document of the Classification Committee of Vestibular Disorders of the Bárány Society and the International Headache Society Exclusion Criteria: Not able to comprehend or able to follow instructions syndromic, other ontological, neurological conditions

Sites / Locations

  • Universiti Malaya Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vestibular Migraine group

Arm Description

Written, verbal and pictorial descriptions will be provided for each participant regarding lifestyle modifications and vestibular rehabilitation exercise

Outcomes

Primary Outcome Measures

Paediatric Dizziness Handicap Inventory
This measure assesses impact of dizziness in children between 5-12 years
Dizziness Handicap Inventory
This measure assesses impact of dizziness in children above 12 -18

Secondary Outcome Measures

Full Information

First Posted
May 8, 2023
Last Updated
June 19, 2023
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05914207
Brief Title
Non-Pharmacological Treatment of Vestibular Migraine in Children and Adolescent
Official Title
Effects of Lifestyle Modifications and Vestibular Rehabilitation Therapy in Children and Adolescents With Vestibular Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vestibular dysfunction has traditionally been linked to various conditions that affect older adults. Recent studies have shown that children and adolescents suffer from vestibular impairments, yet the numbers are still low due to some factors, including the non-typical presentations. Vestibular migraine has been found to be the most common condition of vestibular dysfunction among children and adolescents. Nonetheless, most children remain undiagnosed due to lack awareness and vague clinical presentations. Parallel to that, there has been no consensus regarding the management algorithm. Most children are managed with pharmacological management extrapolated from the adult algorithm. Many clinicians fail to understand that pharmacological treatments are not sustainable long-term and should focus on lifestyle modifications such as sleep and dietary habits and other non-pharmacological treatments such as deep breathing exercises and vestibular rehabilitation therapy. This study aims to investigate the effect of non-pharmacological treatment in managing children and adolescents with VM. The investigators will use a standardised questionnaire before and after interventions to investigate the effect of lifestyle modifications, simple vestibular rehabilitation exercises and deep breathing techniques in children and adolescents with VM. Lifestyle modifications and vestibular rehabilitation exercise is a more sustainable way of managing children and adolescents with VM, avoiding the side effects of medication, and is more cost-effective. If the non-pharmacological treatment shows promising results, the investigators will continue with multicentre randomised-controlled studies.
Detailed Description
The prevalence of vestibular dysfunction is approximately 30.4% among children and adolescents. Yet, the exact prevalence in children remains a quandary owing to several factors: difficulties describing symptoms and cannot differentiate between true vertigo, unsteadiness, imbalance and light-headedness; secondly, the short-lived nature of some peripheral vestibular conditions results in early and rapid compensation; thirdly, nuanced clinical manifestations of vestibular as well as balance impairment accounts for it being overlooked finally, lack of specialists to manage children with vestibular impairment. Vestibular dysfunction or impairment results in disturbance in the body's balance system. Nonetheless, the most common symptoms include vertigo, nausea, vomiting, intolerance to head motion, nystagmus, unsteady gait, and postural instability. Although clinical presentation may be mild, vestibular dysfunction may impact the quality of life and day-to-day activity, especially school activities such as reading and learning, which are vital for these age groups. Vestibular loss affects cognitive and emotional disturbance related to reflexive deficits, which are related to the role of ascending vestibular pathway to the limbic system and the neocortex's role in the sense of spatial orientation. Vestibular and balance impairment amongst adolescents and young adults will, in the long term, affect social, emotional, psychological and quality of life as vestibular and balance function is imperative in day-to-day life and activity. Vestibular migraine (VM) is found to be the most common cause of dizziness among children and adolescents. The exact prevalence of VM remains unknown as VM is still underdiagnosed due to a lack of awareness amongst parents and attending physicians. It is worth noting that the diagnosis of VM in children and adolescents has traditionally been based on the description of clinical symptoms by the patient or parents/caretaker. The lack of definitive biomarkers and gold-standard diagnostic tools contributes to the delay in diagnosis. The typical battery of investigations, including otological, neurological, ophthalmological, and imaging performed, are oftentimes carried out to rule out other pathological disorders. Vestibular migraine in children is diagnosed based on diagnostic criteria which recently has been put forth by the Committee for the Classification of Vestibular Disorders of the Bar any Society (ICVD) and the Migraine Classification subgroup of the International Headache Society, which describes the three spectrums of VM: Vestibular Migraine of Childhood, probable Vestibular Migraine of Childhood and Recurrent Vertigo of Childhood specific for children under 18 years of age. No gold standard investigation tool exists to diagnose VM, as the available investigations are performed mainly to exclude other conditions such as Meniere's disease and BPPV. Additionally, there is no evidence-based approach for treating VM in children and adolescents, with most recommendations extrapolated from reports on adult and childhood migraine headaches. Only two included studies described medication for VM. Overall, treatment for VM can be divided into pharmacological and non-pharmacological treatment. Pharmacological treatment of VM in children includes those taken during acute attacks and prophylactic treatment. Vestibular suppressants and triptans have been used to abort acute attacks in children and adolescents, although the exact efficacy is still unknown. Non-pharmacological treatment aimed as a prophylactic measure such as eliminating migraine-triggering diet, vestibular rehabilitation, supplements, and a healthy lifestyle. Triggering factors such as increased screen time and usage of immersive technology needs attention parallel to getting adequate sleep, a healthy diet and breathing exercise. Lifestyle modifications have shown significant improvement among adult patients diagnosed with definite VM. Yet, no studies involving children and adolescents. The investigators aim to conduct a study to investigate the effect of lifestyle modifications, simple home-based vestibular rehabilitation and deep breathing exercise in children and adolescents diagnosed with VM. Lifestyle modifications, vestibular rehabilitation exercise and deep breathing exercise is a more sustainable way of managing children and adolescents with VM, avoids the side effects of medication, and is cost-effective. Hypothesis The investigators hypothesise that non-pharmacological treatment which involves lifestyle modifications, home-based vestibular rehabilitation therapy and deep relaxation breathing, will be effective in controlling and reducing the symptoms of vestibular migraine in children and adolescents. Innovation The majority of the studies on pharmacological interventions for vestibular migraine revolve around adult patients. Although the optimal treatment algorithm among adult vestibular migraine remains debatable, the effect of lifestyle modifications in vestibular migraine adult patients has shown promising results. The current research is innovative as the investigators will use an elaborate guide of lifestyle modifications which focuses on the child's dietary, sleep, and lifestyle habits, including increased physical activity, reduction of screen time as well as incorporating simple home-based vestibular rehabilitation therapy and deep breathing exercise. All children and adolescents will be diagnosed with vestibular migraine of childhood according to the Barany Consensus criteria. The investigators will divide the participants into 2 groups: children and adolescents. The investigators believe that the proposed investigation will be a more sustainable way to control, reduce vestibular migraine symptoms, and improve the overall quality of life among the participants. The findings from this research will be the foundation and pave the way for future larger-scale multicentre studies. Research plan The investigators propose that an elaborate guide to lifestyle modifications focusing on the child's dietary, sleep, lifestyle habits, in addition to simple home-based vestibular rehabilitation therapy and deep breathing exercise, will reduce and improve vestibular symptoms in children and adolescents. No studies on non-pharmacological intervention among children and adolescents with vestibular migraine have been published. Yet, data involving adult patients have shown promising results, although no study involving adult patients with vestibular migraine has looked into the effect of lifestyle modifications which includes dietary and sleep habits, in addition to incorporating vestibular rehabilitation therapy and deep breathing exercise in a single study. Justification of the study Lifestyle modifications have successfully prevented Vestibular migraine (VM) in the adult study. No studies involving children and adolescents with VM have been carried out. The investigators aim to conduct a study to investigate the effect of lifestyle modifications and simple vestibular rehabilitation in children and adolescents diagnosed with VM. Lifestyle modifications and vestibular rehabilitation exercise is a more sustainable way of managing children and adolescents with VM, avoiding the side effects of medication and being cost-effective. It is important to investigate the effects of lifestyle modifications on VM because the underlying causes of vestibular migraine are unclear. Our modifications include food triggers, restful sleep, exercise, eating regularity, vestibular rehabilitation, and deep breathing exercise. The investigators hypothesize comprehensive lifestyle modifications, vestibular rehabilitation, and deep breathing exercise will improve vestibular migraine symptoms. This project is important because vestibular migraine is reported to be one of the most common causes of vertigo, and interventions useful for other migraine types or vestibular symptoms may not be effective for VM in children and adolescents. If the investigators demonstrate improvement with comprehensive lifestyle modifications, the investigators will continue the line of investigation with randomized, controlled studies. This work furthers our goal of helping children and adolescents with VM. Main Objective To investigate the effects of elaborate lifestyle modifications, vestibular rehabilitation therapy and deep breathing exercise among children and adolescents with vestibular migraine. Specific Objective To determine the effect of lifestyle modifications, vestibular rehabilitation therapy and deep breathing exercise on the paediatric Dizziness Handicap Inventory (P-DHI)[5-12] and Dizziness Handicap Inventory (DHI) [13-18] pre and post-intervention To determine the effect of lifestyle modifications, vestibular rehabilitation therapy and deep breathing exercise on the overall quality of life pre and post-intervention Hypothesis Comprehensive lifestyle modifications will improve the self-perceived impact of the symptoms of dizziness and headache in individuals with vestibular migraine. Study endpoints To determine the outcome of lifestyle modifications, vestibular rehabilitation and deep breathing exercises in children and adolescents with VM Methodology Study Type and Design Study design: Exploratory Prospective cross-sectional study Duration: 2 years Subjects: Children and Adolescents aged between 5 to 18 years Study population: Patients aged between 5-18 years of age attending the Paediatric Vestibular and balance (ENT) clinic Patients aged between 5 to 18 years old will be screened based on inclusion and exclusion criteria. Once the patient or parent/caretaker consents to participate in the study, the patient will be interviewed to complete a proforma, including the patient's socio-demographic, past medical history, otological, vestibular and balance complaints, and otoscopic examination. The patient, parent/caretaker will fill P-DHI or the DHI questionnaire at the first visit. This will be followed by a hearing assessment with pure tone audiometry and tympanometry, a routine examination for children and adolescents with vestibular symptoms. This will be followed by bedside vestibular assessment with video head impulse test (VHIT), cervical vestibular evoked myogenic potential (cVEMP), and subjective visual vertical (SVV). All test procedures were performed using a non-invasive technique and were explained to all participants before starting. FLOWCHART Patients aged 5-18 years fulfill the Barany criteria of VM Socio-demographic, Otological, Vestibular Screening st visit P-DHI (5-12yrs) or DHI (13-18) Lifestyle modifications + VRT regime nd visit 4 weeks, 8 weeks: repeat P-DHI (5-12yrs) or DHI (13-18) Study Population Children and adolescents aged between 5 to 18 years attending UMMC or in the community, either students in University Malaya or secondary school students in Klang Valley. Withdrawal Criteria: Subjects can choose to withdraw at any time. However, it is worth noting that all the investigations included in this study are safe. Sample Size: 60 (Pilot study) Post-hoc power analysis will be done following data collection Study Duration and Timeline: 2 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Migraine
Keywords
Children, Adolescent, Non-pharmacological, lifestyle modifications, vestibular rehabilitation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children and adolescents who are diagnosed with Vestibular Migraine
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Migraine group
Arm Type
Experimental
Arm Description
Written, verbal and pictorial descriptions will be provided for each participant regarding lifestyle modifications and vestibular rehabilitation exercise
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modifications
Intervention Description
Written suggestions on lifestyle modifications including duration of sleep, meal frequency, reduce screen time, exercise duration, food to avoid.
Intervention Type
Other
Intervention Name(s)
Vestibular rehabilitation exercise
Intervention Description
Each participant will be taught simple home-based vestibular rehabilitation exercise, which needs to be repeated
Primary Outcome Measure Information:
Title
Paediatric Dizziness Handicap Inventory
Description
This measure assesses impact of dizziness in children between 5-12 years
Time Frame
This measure is carried after one month
Title
Dizziness Handicap Inventory
Description
This measure assesses impact of dizziness in children above 12 -18
Time Frame
This measure is carried out after one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children and adolescents between 5-18 years Diagnosed with vestibular migraine based on the Diagnostic criteria consensus document of the Classification Committee of Vestibular Disorders of the Bárány Society and the International Headache Society Exclusion Criteria: Not able to comprehend or able to follow instructions syndromic, other ontological, neurological conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeyasakthy Saniasiaya, MD, MMED ORL
Phone
0126841223
Email
jeyasakthy@um.edu.my
Facility Information:
Facility Name
Universiti Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
500603
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeyasakthy Saniasiaya, MD, MMED ORL
Phone
+60126841223
Email
jeyasakthy@um.edu.my

12. IPD Sharing Statement

Learn more about this trial

Non-Pharmacological Treatment of Vestibular Migraine in Children and Adolescent

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