Clinical Research Directory
Browse clinical research sites, groups, and studies.
MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction
Sponsor: Shanghai 6th People's Hospital
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.
Official title: The Clinical Trial Protocol: MRI Performance and Risk Factors of Bilateral Vestibular Hypofunction: A Multi-center Cross-sectional Study
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2024-10-11
Completion Date
2029-12-31
Last Updated
2026-07-16
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China