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Recruiting NCT06228196

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

— Observational BPPV Vertigo Vertigo, Peripheral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simultaneous cortico-spinal magnetic resonance imaging, Serum.
Who it may be relevant to
Registry conditions: BPPV, Vertigo, Vertigo, Peripheral. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Differences between patients with BPPV and control group in brain structure [Time frame: baseline and 1 and 6 months]
  • Differences between two groups in brain function [Time frame: baseline and 1 and 6 months]
  • Changes on vertigo symptoms [Time frame: baseline and 1 and 6 months]
  • Changes on vertigo symptoms [Time frame: baseline and 1 and 6 months]
  • Changes on vertigo symptoms [Time frame: baseline and 1 and 6 months]
  • Difference in blood markers between the two groups [Time frame: baseline and 1 and 6 months]
  • Difference in blood markers between the two groups [Time frame: baseline and 1 and 6 months]
  • Difference in blood markers between the two groups [Time frame: baseline and 1 and 6 months]
Secondary outcome measures (8)
  • Differences in Fatigue between the two groups [Time frame: baseline and 1 and 6 months]
  • Differences in Sleep between the two groups [Time frame: baseline and 1 and 6 months]
  • Differences in cognition between the two groups [Time frame: baseline and 1 and 6 months]
  • Differences in executive function between the two groups [Time frame: baseline and 1 and 6 months]
  • Difference in anxiety between the two groups [Time frame: baseline and 1 and 6 months]
  • Difference in depression between the two groups [Time frame: baseline and 1 and 6 months]
  • Differences in verbal memory and working memory between the two groups [Time frame: baseline and 1 and 6 months]
  • Differences in auditory attention between the two groups [Time frame: baseline and 1 and 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an

Identifiers

NCT: NCT06228196 · XJTU1AF2023LSK-566

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗