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

Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228196
• Other study ID #: XJTU1AF2023LSK-566
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yuan Wang, M.D.
• Phone: 0086-13324598144
• Email: wangyuan8003[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• BPPV
• Dizziness
• Vertigo
• Vertigo, Peripheral

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes on vertigo symptoms	Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)	baseline and 1 and 6 months
Primary	Changes on vertigo symptoms	Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)	baseline and 1 and 6 months
Primary	Changes on vertigo symptoms	Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)	baseline and 1 and 6 months
Primary	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
Primary	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
Primary	Difference in blood markers between the two groups	Inflammatory index in the blood sample is neutrophils/lymphocytes	baseline and 1 and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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