Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China

Обзор

The main objective is to analyze the abnormality of physical condition, mental health and blood examination of the patients with benign paroxysmal positional vertigo (BPPV). Besides, the investigators aim to establish a database of BPPV based on multimodal magnetic resonance imaging data in the brain to identify high-risk patients with residual dizziness (RD) and systematically establish the comprehensive assessment system for the precise diagnosis, treatment and recovery of RD, optimize the tactics of BPPV management in China.

Подробное описание

This is an observational, longitudinal, and single-center study. Confirmed BPPV cases will complete the following programs before and after 1 and 6 months of treatment for exploring biological mechanism and predictive biomarkers of BPPV: 1) fill in the behavioral psychological scales, 2) submit blood samples at a local laboratory, 3) receive 3 times brain MRI scan. The healthy controls will complete the same programs as BPPV-group mentioned above only at the time of inclusion. The investigators will establish the brain MRI database containing neuropsychological scales and blood parameters of BPPV in China.

Вмешательства

• Устройство Simultaneous cortico-spinal magnetic resonance imaging, Serum
  Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.

Первичные конечные точки

• Differences between patients with BPPV and control group in brain structure [Срок оценки: baseline and 1 and 6 months]
• Differences between two groups in brain function [Срок оценки: baseline and 1 and 6 months]
• Changes on vertigo symptoms [Срок оценки: baseline and 1 and 6 months]
• Changes on vertigo symptoms [Срок оценки: baseline and 1 and 6 months]
• Changes on vertigo symptoms [Срок оценки: baseline and 1 and 6 months]
• Difference in blood markers between the two groups [Срок оценки: baseline and 1 and 6 months]
• Difference in blood markers between the two groups [Срок оценки: baseline and 1 and 6 months]
• Difference in blood markers between the two groups [Срок оценки: baseline and 1 and 6 months]

Вторичные конечные точки (8)

• Differences in Fatigue between the two groups [Срок оценки: baseline and 1 and 6 months]
• Differences in Sleep between the two groups [Срок оценки: baseline and 1 and 6 months]
• Differences in cognition between the two groups [Срок оценки: baseline and 1 and 6 months]
• Differences in executive function between the two groups [Срок оценки: baseline and 1 and 6 months]
• Difference in anxiety between the two groups [Срок оценки: baseline and 1 and 6 months]
• Difference in depression between the two groups [Срок оценки: baseline and 1 and 6 months]
• Differences in verbal memory and working memory between the two groups [Срок оценки: baseline and 1 and 6 months]
• Differences in auditory attention between the two groups [Срок оценки: baseline and 1 and 6 months]

Критерии участия

Критерии включения

• Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV

Критерии исключения

• History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Xi'an Jiaotong University — Сиань

Идентификаторы

NCT: NCT06228196 · XJTU1AF2023LSK-566

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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