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

Recruiting

• Conditions: BPPV; Vertigo, Peripheral; Vertigo
• Interventions: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

• Registration Number: NCT06228196
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study Start: 2024-01-08
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BPPV patients	Simultaneous cortico-spinal magnetic resonance imaging, Serum	Confirmed diagnosis of BPPV
Healthy controls	Simultaneous cortico-spinal magnetic resonance imaging, Serum	Healthy subjects who have not had BPPV

Primary Outcome Measures

Name	Time	Method
Differences between patients with BPPV and control group in brain structure	baseline and 1 and 6 months	The changes of brain volume (mm3) are evaluated by structural MRI
Differences between two groups in brain function	baseline and 1 and 6 months	The changes of brain functional connectivity intensity are evaluated by functional MRI
Changes on vertigo symptoms	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	baseline and 1 and 6 months	Inflammatory index in the blood sample is neutrophils/lymphocytes

Secondary Outcome Measures

Name	Time	Method
Differences in Sleep between the two groups	baseline and 1 and 6 months	Sleep quality is assessed with Pittsburgh Sleep Quality Index (PSQI). A higher score corresponding to a worse sleep quality.
Differences in cognition between the two groups	baseline and 1 and 6 months	The cognition is assessed with Montreal Cognitive Assessment (MoCA). Higher scores (0-30) are related to a better performance.
Differences in executive function between the two groups	baseline and 1 and 6 months	The executive function is assessed with Trail Making Test A and B. Participants are asked to connect sequential numbers (TMT-A) and interconnect sequential numbers and letters (TMT-B).
Differences in verbal memory and working memory between the two groups	baseline and 1 and 6 months	Verbal memory is assessed with the Auditory Verbal Learning Test (AVLT). A 12-word list are read by examiner three times and participants are asked to recall them followed by each presentation, which was called "immediate recall". The "short delayed recall" and "long delayed recall" ask the participants to recall the above 12-word list 5 minutes and 20 minutes later, the correctly recalled number of words are recorded. Finally, the subjects are instructed to recognize the learned words from a 24-words list which consisted of above learned 12-words list and a new unlearned 12-words list. Working memory is assessed with the Digit Span Backward. Participants are asked to repeat the numbers in the reverse order the examiner read them aloud and a higher score corresponding to a better outcome.
Differences in Fatigue between the two groups	baseline and 1 and 6 months	Fatigue is assessed with the Multidimensional Fatigue Inventory (MFI). A higher score represents a worse outcome. The MFI is a 20-item self-report instrument covering four dimensions (general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity) designed to measure fatigue.
Difference in anxiety between the two groups	baseline and 1 and 6 months	Anxiety is assessed with Beck Anxiety Inventory (BAI). A higher score corresponding to more severe anxiety symptoms.
Differences in auditory attention between the two groups	baseline and 1 and 6 months	Auditory attention is assessed with the Digit Span Forward. Participants are asked to repeat the numbers in the order the examiner read them aloud and a higher score corresponding to a better outcome.
Difference in depression between the two groups	baseline and 1 and 6 months	Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9). A higher score corresponding to more severe depression symptoms.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China