MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction

NCT07709143 | Recruiting

• 2 other identifiers: 2024-KY-229(K)2023YFC2508003
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bilateral Vestibular Hypofunction; Bilateral Vestibulopathy; Presbyvestibulopathy

Keywords

Bilateral vestibular hypofunction; Bilateral vestibulopathy; Presbyvestibulopathy; Resting-state functional MRI; Diffusion tensor imaging; Diffusion kurtosis imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 month after enrollment

Secondary Outcomes (4)

• Vestibular Disorders Activities of Daily Living Scale

  Within 1 month after enrollment

• Hospital Anxiety and Depression Scale

  Within 1 month after enrollment

• Visual Analog Scale

  Within 1 month after enrollment

• Video Head Impulse Test

  Within 1 month after enrollment

Study Arms (2)

patients

Participants diagnosed with bilateral vestibular hypofunction, including bilateral vestibulopathy or presbyvestibulopathy. Participants in this group will undergo vestibular function tests, magnetic resonance imaging, patient-reported clinical scales, and laboratory assessments.

Diagnostic Test: Multimodal Neuroimaging and Vestibular Function Assessment

healthy controls

Age-matched healthy control participants without bilateral vestibular hypofunction. Participants in this group will undergo the same study assessments, including vestibular function tests, magnetic resonance imaging, patient-reported clinical scales, and laboratory assessments, as applicable according to the study protocol.

Diagnostic Test: Multimodal Neuroimaging and Vestibular Function Assessment

Interventions

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.

Also known as: rs-fMRI, DTI, DKI, Vestibular function tests

healthy controls; patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in alternative pharmaceutical or medical device clinical trials within the preceding 3-month period.
• Clinically significant head movement restrictions.
• Subjects assessed by investigators as unsuitable for study participation.
• Individuals with contraindications for MRI, including cardiac pacemakers, implanted electronic devices, claustrophobia, metallic implants incompatible with magnetic resonance imaging and medications potentially compromising MRI scan safety.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from enrolled participants for laboratory assessments, including biochemical, metabolic, inflammatory, and anti-inflammatory biomarkers. Planned assessments include lipid profile, glucose metabolism-related indicators, liver and renal function-related indicators, inflammatory biomarkers, anti-inflammatory biomarkers, and apolipoprotein E genotyping. Samples may be used for DNA extraction for the planned genotyping analysis.

MeSH Terms

Conditions

Bilateral Vestibulopathy

Interventions

Vestibular Function Tests

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Yuchen Jin, Master of Medicine

CONTACT

+86 17317962393; achanjindoctor@163.com

Dongzhen Yu

CONTACT

+86 18930173980; 7250012023@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngology Institute of Shanghai Jiao Tong University, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: October 11, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified IPD and supporting information will become available beginning 1 year after publication of the main study results and will remain available for 5 years following publication.
• Access Criteria: Access will be granted to qualified researchers who submit a methodologically sound research proposal for scientific purposes related to bilateral vestibular hypofunction, vestibular disorders, neuroimaging, or related clinical research. Requests will be reviewed by the principal investigator and the relevant ethics committee. Data will be shared only after approval of the request and execution of a data access agreement. Shared data may include de-identified clinical scale scores, vestibular function test results, laboratory variables, and processed neuroimaging-derived measures. Direct identifiers and raw imaging data will not be shared unless specifically approved by the ethics committee.

Locations

CN (1)