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Clinical Trials/NCT06228196
NCT06228196
Recruiting
N/A

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

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country150 target enrollmentJanuary 8, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
BPPV
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Enrollment
150
Locations
1
Primary Endpoint
Differences between patients with BPPV and control group in brain structure
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2024
End Date
September 30, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Differences between patients with BPPV and control group in brain structure

Time Frame: baseline and 1 and 6 months

The changes of brain volume (mm3) are evaluated by structural MRI

Differences between two groups in brain function

Time Frame: baseline and 1 and 6 months

The changes of brain functional connectivity intensity are evaluated by functional MRI

Changes on vertigo symptoms

Time Frame: 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

Time Frame: baseline and 1 and 6 months

Inflammatory index in the blood sample is neutrophils/lymphocytes

Secondary Outcomes

  • 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)

Study Sites (1)

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