[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647440":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":29,"locations":39,"responsibleParty":62,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":10,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Shanghai 6th People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"patients",null,"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.",[13],"Diagnostic Test: Multimodal Neuroimaging and Vestibular Function Assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[15,9],[25,26,27,28],"rs-fMRI","DTI","DKI","Vestibular function tests",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Yuchen Jin, Master of Medicine","CONTACT","+86 17317962393","achanjindoctor@163.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Dongzhen Yu","+86 18930173980","7250012023@shsmu.edu.cn",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital","RECRUITING","Shanghai","Shanghai Municipality","200233","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55,59],{"name":56,"role":32,"phone":57,"phoneExt":10,"email":58},"Luyang Pang","+86 021 2405 6428","liuyuangcp@163.com",{"name":60,"role":61,"phone":10,"phoneExt":10,"email":10},"Dongzhen Yu, MD","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"YUCHEN JIN","Otolaryngology Institute of Shanghai Jiao Tong University, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","100647440","mri-performance-and-risk-factors-in-bilateral-vestibular-hypofunction-100647440",false,"NCT07709143","MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction","The Clinical Trial Protocol: MRI Performance and Risk Factors of Bilateral Vestibular Hypofunction: A Multi-center Cross-sectional Study","MPARFIBVH","Inclusion Criteria:\n\n1. Sex unrestricted, age over 16 years old.\n2. Patients meeting the diagnostic criteria for bilateral vestibulopathy (BVP) and presbyvestibulopathy (PVP)\n3. 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.\n\nExclusion Criteria:\n\n1. Administration of medications potentially affecting cerebral function, including psychotropic drugs (antidepressants, anxiolytics) or prolonged anti-vertigo medication usage.\n2. Presence of severe cardiovascular or systemic medical conditions, organ dysfunction, or significant mobility impairments.\n3. Significant local or systemic diseases, or psychiatric disorders causing cognitive impairment, specifically schizophrenia, major depressive disorder, or generalized anxiety disorder.\n4. Pregnant or lactating women.\n5. Participation in alternative pharmaceutical or medical device clinical trials within the preceding 3-month period.\n6. Clinically significant head movement restrictions.\n7. Subjects assessed by investigators as unsuitable for study participation.\n8. 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.",true,"ALL","16 Years",{"count":77,"type":78},120,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nParticipants 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.\n\nThe 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.",[82,83,84],"Bilateral Vestibular Hypofunction","Bilateral Vestibulopathy","Presbyvestibulopathy",[86,87,84,88,89,90],"Bilateral vestibular hypofunction","Bilateral vestibulopathy","Resting-state functional MRI","Diffusion tensor imaging","Diffusion kurtosis imaging","2026-07-11",{"date":93,"type":94},"2026-07-16","ACTUAL",{"date":96,"type":94},"2024-10-11",{"date":98,"type":78},"2029-12-31",{"name":5,"class":6},1]