MPARFIBVHFonction vestibulaire, imagerie cérébrale et biomarqueurs sanguins dans l'hypofonction vestibulaire bilatérale
Cette étude vise à observer et à comprendre l'impact de l'Hypofonction Vestibulaire Bilatérale sur votre fonction vestibulaire, l'imagerie cérébrale et les biomarqueurs sanguins, en utilisant un questionnaire appelé l'Inventaire du Handicap Vertigineux pour évaluer votre déficience vestibulaire perçue.
Test diagnostique Data
+ diagnosticTest Data
Données recueillies à un instant précis - TransversaleMaladies de l'oreille+6
+ Maladies du Labyrinthe
+ Maladies du système nerveux
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 11 octobre 2024
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.120 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 16 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital
Shanghai, ChinaOuvrir shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital dans Google Maps