MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction

ConditionsBilateral Vestibular Hypofunction Bilateral Vestibulopathy Presbyvestibulopathy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age16+

SponsorShanghai 6th People's Hospital

About this trial

Bilateral vestibular hypofunction (BVH) is a chronic disorder in which the balance organs or vestibular pathways on both sides do not work normally. People with BVH may experience unsteadiness, blurred or unstable vision during head movement, difficulty walking, and an increased risk of falls. At present, there are limited targeted medical treatments, and the reasons why symptoms are severe in some patients but mild in others are not fully understood.

This prospective, multicenter, cross-sectional study will investigate the relationships among vestibular function, brain structure and function, blood biomarkers, patient-reported symptoms, and disease severity in people with BVH. The study will enroll approximately 120 participants from five medical centers in China, including about 80 patients with BVH and 40 age-matched healthy controls.

Participants will undergo vestibular function tests, including videonystagmography, caloric testing, sinusoidal harmonic acceleration testing, video head impulse testing, vestibular evoked myogenic potentials, and sensory organization testing. Brain imaging will include resting-state functional magnetic resonance imaging, diffusion tensor imaging, and diffusion kurtosis imaging. Participants will also complete questionnaires related to dizziness, anxiety and depression, daily activities, and symptom severity, and blood samples will be collected for biochemical and inflammatory marker testing.

The main hypothesis is that BVH severity is associated with measurable changes in vestibular function, brain functional connectivity and microstructure, inflammatory or metabolic biomarkers, and patient-reported quality of life. By combining clinical testing, neuroimaging, laboratory measures, and symptom scales, this study aims to improve understanding of the mechanisms of BVH and to support future development of more individualized diagnostic and rehabilitation strategies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Sex unrestricted, age over 16 years old.

Patients meeting the diagnostic criteria for bilateral vestibulopathy (BVP) and presbyvestibulopathy (PVP)

Participants or their legal representatives, who comprehensively understand the research purpose, demonstrate sufficient compliance with the study protocol, have the ability to communicate and cooperate, and have signed the informed consent form.

Disqualifiers

Administration of medications potentially affecting cerebral function, including psychotropic drugs (antidepressants, anxiolytics) or prolonged anti-vertigo medication usage.

Presence of severe cardiovascular or systemic medical conditions, organ dysfunction, or significant mobility impairments.

Significant local or systemic diseases, or psychiatric disorders causing cognitive impairment, specifically schizophrenia, major depressive disorder, or generalized anxiety disorder.

Pregnant or lactating women.

Trial population

The study population will consist of participants aged over 16 years, including patients diagnosed with bilateral vestibular hypofunction (BVH) and age-matched healthy controls. Patients with BVH will include individuals meeting the diagnostic criteria for bilateral vestibulopathy (BVP) or presbyvestibulopathy (PVP). A total of 120 participants will be enrolled from five medical centers, including 80 BVH patients and 40 healthy controls. All participants must be able to understand the study procedures, comply with the protocol, communicate and cooperate with investigators, and provide written informed consent.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Multimodal Neuroimaging and Vestibular Function Assessment
Diagnostic test
Participants will undergo multimodal neuroimaging and vestibular function assessments, including resting-state functional magnetic resonance imaging (rs-fMRI), diffusion tensor imaging (DTI), diffusion kurtosis imaging (DKI), and standardized vestibular function tests. Vestibular assessments include videonystagmography (VNG), caloric test (CT), sinusoidal harmonic acceleration test (SHAT), video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), and sensory organization test (SOT). Participant-reported clinical scales and laboratory examinations will also be collected to evaluate the relationship between vestibular dysfunction, brain function, biochemical variables, quality of life, and BVH severity.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: patients1 intervention

Group B: healthy controls1 intervention

Trial outcomes

Primary outcomes

Dizziness Handicap Inventory

The Dizziness Handicap Inventory is a 25-item questionnaire used to assess perceived vestibular disability. Each item is scored using three response categories of 0, 2, or 4, with a total score ranging from 0 to 100; higher scores indicate greater dizziness-related handicap. Severity is categorized as mild 0-30, moderate 30-60, and severe 61-100.

Time frame