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

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.

Study Overview

• Status: Recruiting
• Conditions: BPPV; Vertigo; Vertigo, Peripheral
• Intervention / Treatment: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Yuan Wang, M.D.; Phone Number: 0086-13324598144; Email: wangyuan8003@126.com
• Study Contact Backup: Name: Ming Zhang, PhD; Phone Number: +8618991232265; Email: zmmri@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Yuan Wang, M.D.; Phone Number: 0086-13324598144; Email: wangyuan8003@126.com
      • Contact: Ming Zhang, PhD; Phone Number: 0086-18991232265; Email: zmmri@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out in the First Affiliated Hospital Xi'an Jiaotong University for patients who had diagnosis of BPPV by the Dix-Hallpike maneuver or Supine Roll test.

The healthy control population will be searched in the primary care services, media and social networks.

All participants will sign informed consent.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BPPV patients; Confirmed diagnosis of BPPV	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.
Healthy controls; Healthy subjects who have not had BPPV	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between patients with BPPV and control group in brain structure	The changes of brain volume (mm3) are evaluated by structural MRI	baseline and 1 and 6 months
Differences between two groups in brain function	The changes of brain functional connectivity intensity are evaluated by functional MRI	baseline and 1 and 6 months
Changes on vertigo symptoms	Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)	baseline and 1 and 6 months
Changes on vertigo symptoms	Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)	baseline and 1 and 6 months
Changes on vertigo symptoms	Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)	baseline and 1 and 6 months
Difference in blood markers between the two groups	All subjects underwent fasting vein blood collection of about 5 ml at about 8 a.m. Blood indices related to BPPV and related clinical symptoms were screened, the inflammatory index is interleukin-6（IL-6）	baseline and 1 and 6 months
Difference in blood markers between the two groups	Immunology-related index in the blood sample is superoxide dismutase (SOD)	baseline and 1 and 6 months
Difference in blood markers between the two groups	Inflammatory index in the blood sample is neutrophils/lymphocytes	baseline and 1 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Fatigue between the two groups	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.	baseline and 1 and 6 months
Differences in Sleep between the two groups	Sleep quality is assessed with Pittsburgh Sleep Quality Index (PSQI). A higher score corresponding to a worse sleep quality.	baseline and 1 and 6 months
Differences in cognition between the two groups	The cognition is assessed with Montreal Cognitive Assessment (MoCA). Higher scores (0-30) are related to a better performance.	baseline and 1 and 6 months
Differences in executive function between the two groups	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).	baseline and 1 and 6 months
Difference in anxiety between the two groups	Anxiety is assessed with Beck Anxiety Inventory (BAI). A higher score corresponding to more severe anxiety symptoms.	baseline and 1 and 6 months
Difference in depression between the two groups	Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9). A higher score corresponding to more severe depression symptoms.	baseline and 1 and 6 months
Differences in verbal memory and working memory between the two groups	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.	baseline and 1 and 6 months
Differences in auditory attention between the two groups	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.	baseline and 1 and 6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yuan Wang, M.D., First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vertigo; Neuroimaging; BPPV; Epidemic; residual dizziness
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: XJTU1AF2023LSK-566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No