Non-Pharmacological Treatment of Vestibular Migraine in Children and Adolescent

NCT05914207 | Unknown

• 1 other identifier: MECID.No 2023224-12175
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Migraine

Keywords

Children; Adolescent; Non-pharmacological; lifestyle modifications; vestibular rehabilitation therapy

Outcome Measures

Primary Outcomes (2)

• Paediatric Dizziness Handicap Inventory

  This measure assesses impact of dizziness in children between 5-12 years

  This measure is carried after one month

• Dizziness Handicap Inventory

  This measure assesses impact of dizziness in children above 12 -18

  This measure is carried out after one month

Study Arms (1)

Vestibular Migraine group

EXPERIMENTAL

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

Behavioral: Lifestyle modifications; Other: Vestibular rehabilitation exercise

Interventions

Lifestyle modifications BEHAVIORAL

Written suggestions on lifestyle modifications including duration of sleep, meal frequency, reduce screen time, exercise duration, food to avoid.

Vestibular Migraine group

Vestibular rehabilitation exercise OTHER

Each participant will be taught simple home-based vestibular rehabilitation exercise, which needs to be repeated

Vestibular Migraine group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not able to comprehend or able to follow instructions
• syndromic, other ontological, neurological conditions

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya Medical Centre

Kuala Lumpur, 500603, Malaysia

Location

Central Study Contacts

Jeyasakthy Saniasiaya, MD, MMED ORL

CONTACT

0126841223; jeyasakthy@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Children and adolescents who are diagnosed with Vestibular Migraine

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 22, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

MY (1)