Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Differences between patients with BPPV and control group in brain structure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV
排除标准
- •History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic
结局指标
主要结局
Differences between patients with BPPV and control group in brain structure
时间窗: baseline and 1 and 6 months
The changes of brain volume (mm3) are evaluated by structural MRI
Differences between two groups in brain function
时间窗: baseline and 1 and 6 months
The changes of brain functional connectivity intensity are evaluated by functional MRI
Changes on vertigo symptoms
时间窗: baseline and 1 and 6 months
Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)
Difference in blood markers between the two groups
时间窗: baseline and 1 and 6 months
Inflammatory index in the blood sample is neutrophils/lymphocytes
次要结局
- Differences in Sleep between the two groups(baseline and 1 and 6 months)
- Differences in cognition between the two groups(baseline and 1 and 6 months)
- Differences in executive function between the two groups(baseline and 1 and 6 months)
- Differences in verbal memory and working memory between the two groups(baseline and 1 and 6 months)
- Differences in Fatigue between the two groups(baseline and 1 and 6 months)
- Difference in anxiety between the two groups(baseline and 1 and 6 months)
- Differences in auditory attention between the two groups(baseline and 1 and 6 months)
- Difference in depression between the two groups(baseline and 1 and 6 months)