MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction (MPARFIBVH)

July 11, 2026 updated by: YUCHEN JIN, Shanghai 6th People's Hospital

The Clinical Trial Protocol: MRI Performance and Risk Factors of Bilateral Vestibular Hypofunction: A Multi-center Cross-sectional Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, cross-sectional observational study designed to investigate the clinical, vestibular, neuroimaging, biochemical, and patient-reported characteristics associated with bilateral vestibular hypofunction (BVH). The study will recruit patients with BVH and age-matched healthy controls from five medical centers in China. The planned total sample size is approximately 120 participants, including about 80 patients with BVH and 40 healthy controls.

The main objective of the study is to clarify the relationships among vestibular function, brain structure and function, biochemical variables, patient-reported symptoms, quality of life, and the severity of BVH. The study will also examine patterns of brain activity, functional connectivity, and diffusion-related microstructural changes using resting-state functional magnetic resonance imaging (rs-fMRI), diffusion tensor imaging (DTI), and diffusion kurtosis imaging (DKI). By integrating these assessments, the study aims to identify clinical and biological factors that may be associated with disease severity and functional impairment in BVH.

After providing written informed consent, eligible participants will undergo collection of demographic and clinical information, including age, sex, education, blood pressure, height, weight, and medical history. Participants will then complete a series of vestibular function assessments, neuroimaging examinations, clinical symptom scales, and laboratory tests. The study is observational and cross-sectional; no investigational drug, device, surgical procedure, or therapeutic intervention will be assigned as part of the study.

Vestibular function will be assessed using several complementary tests. Videonystagmography will be used to record and evaluate eye movements, including spontaneous nystagmus, gaze, saccade, and smooth pursuit eye movements. Caloric testing will be used to evaluate bilateral vestibular responsiveness and symmetry. Sinusoidal harmonic acceleration testing will assess vestibulo-ocular reflex performance during rotational stimulation. Video head impulse testing will assess dynamic semicircular canal function. Vestibular evoked myogenic potentials will be used to evaluate otolith-related vestibular function, and sensory organization testing will assess balance control under different sensory conditions.

Neuroimaging will include anatomical magnetic resonance imaging, resting-state functional magnetic resonance imaging, diffusion tensor imaging, and diffusion kurtosis imaging. During magnetic resonance imaging, participants will be instructed to remain still, relax, breathe steadily, keep their eyes closed while remaining awake, and avoid intentional cognitive tasks. Anatomical imaging will be used to screen for intracranial structural abnormalities. Resting-state functional magnetic resonance imaging will be used to examine spontaneous brain activity and functional connectivity. Diffusion tensor imaging and diffusion kurtosis imaging will be used to assess white matter integrity and microstructural tissue features.

Patient-reported assessments will include standardized scales evaluating dizziness-related disability, anxiety and depression symptoms, dizziness severity, and the impact of vestibular symptoms on activities of daily living. These assessments will include the Dizziness Handicap Inventory, Hospital Anxiety and Depression Scale, Visual Analog Scale, and Vestibular Disorders Activities of Daily Living Scale.

Laboratory assessments will include biochemical, metabolic, inflammatory, and anti-inflammatory markers. These measures will include lipid-related indicators, glucose metabolism-related indicators, liver and renal function-related indicators, inflammatory biomarkers, anti-inflammatory biomarkers and apolipoprotein E genotyping, according to the study protocol.

The primary analyses will focus on the relationships between BVH and multimodal objective measures, including neuroimaging indicators and vestibular function test results. Secondary analyses will evaluate associations involving patient-reported scales and laboratory variables. Neuroimaging data will be processed using established software platforms for functional and diffusion imaging analysis. Statistical analyses will be used to compare patients and controls and to explore associations between vestibular function, neuroimaging measures, laboratory biomarkers, symptom burden, and BVH severity.

Participant safety will be monitored throughout the study. Participants may withdraw or be withdrawn from the study if they experience an allergic reaction, a serious adverse event, or another condition judged by the investigators to make continued participation unsuitable. The study has received ethics approval from the Ethics Committee of Shanghai Sixth People's Hospital and will be conducted in accordance with applicable ethical requirements. Written informed consent will be obtained before enrollment.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Recruiting
        • shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital
        • Contact:
        • Principal Investigator:
          • Dongzhen Yu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  1. Sex unrestricted, age over 16 years old.
  2. Patients meeting the diagnostic criteria for bilateral vestibulopathy (BVP) and presbyvestibulopathy (PVP)
  3. 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.

Exclusion Criteria:

  1. Administration of medications potentially affecting cerebral function, including psychotropic drugs (antidepressants, anxiolytics) or prolonged anti-vertigo medication usage.
  2. Presence of severe cardiovascular or systemic medical conditions, organ dysfunction, or significant mobility impairments.
  3. Significant local or systemic diseases, or psychiatric disorders causing cognitive impairment, specifically schizophrenia, major depressive disorder, or generalized anxiety disorder.
  4. Pregnant or lactating women.
  5. Participation in alternative pharmaceutical or medical device clinical trials within the preceding 3-month period.
  6. Clinically significant head movement restrictions.
  7. Subjects assessed by investigators as unsuitable for study participation.
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • DTI
  • rs-fMRI
  • DKI
  • Vestibular function tests
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
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.
Other Names:
  • DTI
  • rs-fMRI
  • DKI
  • Vestibular function tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory
Time Frame: Within 1 month after enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular Disorders Activities of Daily Living Scale
Time Frame: Within 1 month after enrollment
The Vestibular Disorders Activities of Daily Living Scale is a 28-item scale used to assess the impact of vestibular dysfunction on daily functioning. It includes functional, mobility, and social activity subscales; each activity is scored from 1 to 10, with higher scores indicating greater vestibular-related impairment in daily activities.
Within 1 month after enrollment
Hospital Anxiety and Depression Scale
Time Frame: Within 1 month after enrollment
The Hospital Anxiety and Depression Scale is a 14-item questionnaire used to assess anxiety and depression symptoms. Each item is scored from 0 to 3, giving a total score range of 0 to 42; higher scores indicate greater anxiety or depression burden.
Within 1 month after enrollment
Visual Analog Scale
Time Frame: Within 1 month after enrollment
The Visual Analog Scale (VAS) will be used to assess participants' perceived dizziness severity in three conditions: during specific movements or positions (VAS-A), at rest (VAS-B), and during instability or imbalance while standing and/or walking (VAS-C).Each item will be scored from 0 to 10, with 0 indicating no or minimal dizziness-related discomfort and 10 indicating the most severe dizziness-related discomfort imaginable. Higher scores indicate greater perceived dizziness severity.
Within 1 month after enrollment
Video Head Impulse Test
Time Frame: Within 1 month after enrollment
The video head impulse test is used to objectively assess dynamic vestibular function during rapid, unpredictable head rotations while the participant maintains visual fixation on a target. The primary parameter is vestibulo-ocular reflex gain of the six semicircular canals.
Within 1 month after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-229(K)
  • 2023YFC2508003 (Other Grant/Funding Number: National Key Research and Development Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the published results may be shared with qualified researchers upon reasonable request after publication of the main study results, subject to approval by the relevant ethics committee and execution of a data access agreement. Shared data may include 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bilateral Vestibulopathy

Clinical Trials on Multimodal Neuroimaging and Vestibular Function Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe