Bilateral Vestibular HypofunctionMPARFIBVHNCT07709143
MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction
An observational study of Bilateral Vestibular Hypofunction and Bilateral Vestibulopathy, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bilateral Vestibular Hypofunction, Bilateral Vestibulopathy, Presbyvestibulopathy
- What is being tested?
- Multimodal Neuroimaging and Vestibular Function Assessment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Luyang Pang, +86 021 2405 6428, liuyuangcp@163.com
Dongzhen Yu, MD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Multimodal Neuroimaging and Vestibular Function Assessment
- Keywords
- Bilateral vestibular hypofunction, Bilateral vestibulopathy, Presbyvestibulopathy, Resting-state functional MRI, Diffusion tensor imaging, Diffusion kurtosis imaging
- Medical subject headings
- Bilateral Vestibulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Neuroimaging and Vestibular Function AssessmentDiagnostic test
Also called rs-fMRI, DTI, DKI, Vestibular function tests
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Multimodal Neuroimaging and Vestibular Function Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 month after enrollment
Secondary outcomes (4)
Vestibular Disorders Activities of Daily Living Scale
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.
Measured: Within 1 month after enrollment
Hospital Anxiety and Depression Scale
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.
Measured: Within 1 month after enrollment
Visual Analog Scale
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.
Measured: Within 1 month after enrollment
Video Head Impulse Test
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.
Measured: Within 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start11 Oct 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Bilateral Vestibular HypofunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUCHEN JIN, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709143
- Sponsor's protocol ID
- 2024-KY-229(K)
- Other IDs
- 2023YFC2508003
- Acronym
- MPARFIBVH
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kellner E, Dhital B, Kiselev VG, Reisert M. Gibbs-ringing artifact removal based on local subvoxel-shifts. Magn Reson Med. 2016 Nov;76(5):1574-1581. doi: 10.1002/mrm.26054. Epub 2015 Nov 24.
PubMed 26745823Li J, Leng Y, Ma H, Yang F, Liu B, Fan W. Functional reorganization of intranetwork and internetwork connectivity in patients with Meniere's disease. Sci Rep. 2023 Oct 5;13(1):16775. doi: 10.1038/s41598-023-44090-x.
PubMed 37798378McCrum C, Zhu M, Willems P, Visser I, Kastrinou M, van de Berg R, Meijer K, Hallemans A, Herssens N. Assessing gait variability concurrently with dynamic visual acuity on a treadmill in people with bilateral vestibulopathy. J Vestib Res. 2025 May;35(3):113-120. doi: 10.1177/09574271251313806. Epub 2025 Jan 10.
PubMed 39973592Wu P, Cao W, Hu Y, Li H. Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial. BMJ Open. 2019 Jun 18;9(6):e026711. doi: 10.1136/bmjopen-2018-026711.
PubMed 31217316Sotiropoulos SN, Jbabdi S, Xu J, Andersson JL, Moeller S, Auerbach EJ, Glasser MF, Hernandez M, Sapiro G, Jenkinson M, Feinberg DA, Yacoub E, Lenglet C, Van Essen DC, Ugurbil K, Behrens TE; WU-Minn HCP Consortium. Advances in diffusion MRI acquisition and processing in the Human Connectome Project. Neuroimage. 2013 Oct 15;80:125-43. doi: 10.1016/j.neuroimage.2013.05.057. Epub 2013 May 20.
PubMed 23702418Wasserthal J, Neher P, Maier-Hein KH. TractSeg - Fast and accurate white matter tract segmentation. Neuroimage. 2018 Dec;183:239-253. doi: 10.1016/j.neuroimage.2018.07.070. Epub 2018 Aug 4.
PubMed 30086412Wasserthal J, Neher PF, Hirjak D, Maier-Hein KH. Combined tract segmentation and orientation mapping for bundle-specific tractography. Med Image Anal. 2019 Dec;58:101559. doi: 10.1016/j.media.2019.101559. Epub 2019 Sep 12.
PubMed 31542711Jensen JH, Helpern JA, Ramani A, Lu H, Kaczynski K. Diffusional kurtosis imaging: the quantification of non-gaussian water diffusion by means of magnetic resonance imaging. Magn Reson Med. 2005 Jun;53(6):1432-40. doi: 10.1002/mrm.20508.
PubMed 15906300Basser PJ, Mattiello J, LeBihan D. MR diffusion tensor spectroscopy and imaging. Biophys J. 1994 Jan;66(1):259-67. doi: 10.1016/S0006-3495(94)80775-1.
PubMed 8130344Andersson JLR, Sotiropoulos SN. An integrated approach to correction for off-resonance effects and subject movement in diffusion MR imaging. Neuroimage. 2016 Jan 15;125:1063-1078. doi: 10.1016/j.neuroimage.2015.10.019. Epub 2015 Oct 20.
PubMed 26481672Veraart J, Novikov DS, Christiaens D, Ades-Aron B, Sijbers J, Fieremans E. Denoising of diffusion MRI using random matrix theory. Neuroimage. 2016 Nov 15;142:394-406. doi: 10.1016/j.neuroimage.2016.08.016. Epub 2016 Aug 11.
PubMed 27523449Brilliant T D, Takeuchi H, Nouchi R, Yokoyama R, Kotozaki Y, Nakagawa S, Hanawa S, Sekiguchi A, Ikeda S, Sakaki K, Kawata KHDS, Nozawa T, Yokota S, Magistro D, Kawashima R. Loneliness inside of the brain: evidence from a large dataset of resting-state fMRI in young adult. Sci Rep. 2022 May 12;12(1):7856. doi: 10.1038/s41598-022-11724-5.
PubMed 35550564Herssens N, Dobbels B, Moyaert J, Van de Berg R, Saeys W, Hallemans A, Vereeck L, Van Rompaey V. Paving the Way Toward Distinguishing Fallers From Non-fallers in Bilateral Vestibulopathy: A Wide Pilot Observation. Front Neurol. 2021 Mar 1;12:611648. doi: 10.3389/fneur.2021.611648. eCollection 2021.
PubMed 33732204Hassannia F, Misale P, Sulway S, Olmos GV, Dabiri S, Ranalli P, Rutka JA. Effectiveness of vestibular rehabilitation therapy in patients with idiopathic Cerebellar Ataxia with Bilateral Vestibulopathy (iCABV). J Vestib Res. 2022;32(5):479-485. doi: 10.3233/VES-210058.
PubMed 35527586Basta D, Rossi-Izquierdo M, Wonneberger K, Brugnera C, Bittar RSM, Greters ME, Ernst A, Soto-Varela A. Individualized Vibrotactile Neurofeedback Training in Patients with Chronic Bilateral Vestibulopathy. Brain Sci. 2023 Aug 18;13(8):1219. doi: 10.3390/brainsci13081219.
PubMed 37626575
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial Protocol: MRI Performance and Risk Factors of Bilateral Vestibular Hypofunction: A Multi-center Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07709143
- Acronym / sponsor ID
- MPARFIBVH / 2024-KY-229(K)
- Keywords
- Bilateral vestibular hypofunction, Bilateral vestibulopathy, Presbyvestibulopathy, Resting-state functional MRI, Diffusion tensor imaging, Diffusion kurtosis imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Diagnostic Test: Multimodal Neuroimaging and Vestibular Function AssessmentParticipants 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. |
| healthy controls | – | Diagnostic Test: Multimodal Neuroimaging and Vestibular Function AssessmentAge-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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Neuroimaging and Vestibular Function AssessmentAlso: rs-fMRI, DTI, DKI, Vestibular function testsParticipants 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. | Diagnostic test | healthy controls, patients |
Primary outcome
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.
4 secondary outcomes
Vestibular Disorders Activities of Daily Living Scale
Time frame: Within 1 month after enrollment
Hospital Anxiety and Depression Scale
Time frame: Within 1 month after enrollment
Visual Analog Scale
Time frame: Within 1 month after enrollment
Video Head Impulse Test
Time frame: Within 1 month after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 26745823Kellner E, Dhital B, Kiselev VG, Reisert M. Gibbs-ringing artifact removal based on local subvoxel-shifts. Magn Reson Med. 2016 Nov;76(5):1574-1581. doi: 10.1002/mrm.26054. Epub 2015 Nov 24.
- Background: PubMed 37798378Li J, Leng Y, Ma H, Yang F, Liu B, Fan W. Functional reorganization of intranetwork and internetwork connectivity in patients with Meniere's disease. Sci Rep. 2023 Oct 5;13(1):16775. doi: 10.1038/s41598-023-44090-x.
- Background: PubMed 39973592McCrum C, Zhu M, Willems P, Visser I, Kastrinou M, van de Berg R, Meijer K, Hallemans A, Herssens N. Assessing gait variability concurrently with dynamic visual acuity on a treadmill in people with bilateral vestibulopathy. J Vestib Res. 2025 May;35(3):113-120. doi: 10.1177/09574271251313806. Epub 2025 Jan 10.
- Background: PubMed 31217316Wu P, Cao W, Hu Y, Li H. Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial. BMJ Open. 2019 Jun 18;9(6):e026711. doi: 10.1136/bmjopen-2018-026711.
- Background: PubMed 23702418Sotiropoulos SN, Jbabdi S, Xu J, Andersson JL, Moeller S, Auerbach EJ, Glasser MF, Hernandez M, Sapiro G, Jenkinson M, Feinberg DA, Yacoub E, Lenglet C, Van Essen DC, Ugurbil K, Behrens TE; WU-Minn HCP Consortium. Advances in diffusion MRI acquisition and processing in the Human Connectome Project. Neuroimage. 2013 Oct 15;80:125-43. doi: 10.1016/j.neuroimage.2013.05.057. Epub 2013 May 20.
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- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bilateral Vestibular Hypofunction and Bilateral Vestibulopathy, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchen Jin, Master of Medicine (+86 17317962393, achanjindoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (time frame: Within 1 month after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07709143, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.