NCT07493005

Brief Summary

Vestibular migraine (VM) is a common neurological condition characterized by recurrent episodes of dizziness, vertigo, and balance problems, often accompanied by migraine symptoms. These symptoms can significantly impair daily functioning and quality of life. Vestibular rehabilitation (VR) is a non-pharmacological treatment approach aimed at improving balance, reducing dizziness, and promoting central compensation mechanisms. This randomized controlled trial aims to evaluate the effectiveness of virtual reality (VR)-based vestibular rehabilitation in patients with vestibular migraine. Participants diagnosed with definite VM will be randomly assigned to two groups: one group will receive a conventional home-based vestibular rehabilitation program, while the other group will receive the same home-based program in addition to a clinic-based virtual reality rehabilitation program. The intervention will last for four weeks. Clinical outcomes will be assessed before and after the intervention using both objective and subjective measures, including functional vestibulo-ocular reflex (VOR) performance, postural control, balance, dizziness severity, psychological status, and quality of life. The study aims to determine whether adding virtual reality-based rehabilitation to conventional home exercises provides additional benefits in improving balance, reducing symptoms, and enhancing functional outcomes in patients with vestibular migraine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 19, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Vestibular MigraineVirtual RealityVestibular RehabilitationBalanceDizzinessFunctional OutcomesRandomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • Change in balance performance measured by Sensory Organization Test (SOT)

    Postural control will be assessed using the Sensory Organization Test (SOT), which evaluates the participant's ability to maintain balance under different sensory conditions by integrating visual, vestibular, and somatosensory inputs.

    Baseline and 4 weeks

  • Change in functional vestibulo-ocular reflex performance measured by the Functional Head Impulse Test (fHIT)

    Functional vestibulo-ocular reflex performance will be assessed using the Functional Head Impulse Test (fHIT), which evaluates gaze stabilization during rapid head movements.

    Baseline and 4 weeks

  • Change in dynamic balance measured by the Limits of Stability test (LOS)

    Dynamic balance will be assessed using the Limits of Stability (LOS) test, which measures the ability to voluntarily shift the center of gravity within the base of support without losing balance.

    Baseline and 4 weeks

Secondary Outcomes (8)

  • Change in dizziness severity measured by the Visual Analog Scale (VAS)

    Baseline and 4 weeks

  • Change in balance-related symptom severity measured by the Visual Analog Scale (VAS)

    Baseline and 4 weeks

  • Change in dizziness-related disability measured by the Dizziness Handicap Inventory (DHI)

    Baseline and 4 weeks

  • Change in activities of daily living measured by the Vestibular Disorders Activities of Daily Living Scale (VADL)

    Baseline and 4 weeks

  • Change in functional gait performance measured by the Functional Gait Assessment (FGA)

    Baseline and 4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Home-Based Vestibular Rehabilitation

ACTIVE COMPARATOR

Participants in this group will receive an individualized home-based vestibular rehabilitation program. The program will include adaptation exercises (vestibulo-ocular reflex training), habituation exercises, substitution strategies, and balance training tailored to the patient's symptoms. Participants will be instructed to perform the exercises daily, three times per day, over a period of four weeks. Compliance will be monitored through regular follow-up and communication.

Behavioral: Home-Based Vestibular Rehabilitation

Virtual Reality-Based Vestibular Rehabilitation + Home-Based Vestibular Rehabilitation

EXPERIMENTAL

Participants in this group will receive the same individualized home-based vestibular rehabilitation program as the control group. In addition, they will undergo clinic-based virtual reality-based vestibular rehabilitation sessions twice per week for four weeks. The virtual reality program will include tasks such as optokinetic stimulation, head-eye coordination, target tracking, limits of stability training, optical flow exposure, spatial navigation, and simulated environments designed to induce controlled sensory conflict and improve balance and postural control.

Behavioral: Virtual Reality-Based Vestibular Rehabilitation

Interventions

Intervention 1 - Home-Based Vestibular Rehabilitation This intervention consists of an individualized home-based vestibular rehabilitation program designed according to each participant's symptom profile. The program includes adaptation exercises (vestibulo-ocular reflex training), habituation exercises targeting motion sensitivity, substitution strategies, and balance training. Participants will be instructed to perform the exercises three times daily, with multiple repetitions, over a four-week period. The program will be explained and demonstrated by a clinician, and participants will be provided with written and visual instructions. Adherence will be monitored through regular follow-up and weekly contact.

Home-Based Vestibular Rehabilitation

This intervention consists of a clinic-based virtual reality-based vestibular rehabilitation program administered in addition to the home-based program. Participants will attend supervised sessions twice per week for four weeks, with each session lasting approximately 30 minutes. The virtual reality program includes structured tasks such as optokinetic stimulation, head-eye coordination training, target tracking, limits of stability exercises, optical flow exposure, spatial navigation, and simulated environments. These tasks are designed to induce controlled sensory conflict, enhance vestibular compensation, and improve postural control and functional balance in a safe and interactive environment.

Virtual Reality-Based Vestibular Rehabilitation + Home-Based Vestibular Rehabilitation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of definite vestibular migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
  • Age between 18 and 60 years
  • Confirmation of vestibular migraine diagnosis using a validated diagnostic scale
  • Not receiving acute pharmacological treatment for vestibular migraine at the time of enrollment
  • Ability to perform activities of daily living independently
  • No visual impairment or ocular disease that would interfere with assessment or rehabilitation
  • Ability to understand and comply with study procedures
  • Provision of written informed consent

You may not qualify if:

  • Medical contraindications to head movements required for vestibular rehabilitation (e.g., severe cervical disorders)
  • Intolerance to virtual reality equipment or conditions preventing its use
  • Presence of severe comorbid conditions (e.g., life-threatening disease, severe cognitive impairment, neurological disorder, or severe psychiatric disorder)
  • Presence of central nervous system disorders
  • Diagnosis of vestibular disorders other than vestibular migraine
  • Inability or unwillingness to perform home-based or virtual reality-based vestibular rehabilitation
  • Incomplete participation in required assessment procedures
  • Physical disability preventing independent walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulce Kirazli, PhD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

March 1, 2025

Primary Completion

November 1, 2025

Study Completion

February 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations