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NCT Number: NCT06228196

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Device

Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.

Primary outcomes

  1. 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

  2. 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

  3. Changes on vertigo symptoms

    Time frame: baseline and 1 and 6 months

    Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)

  4. Changes on vertigo symptoms

    Time frame: baseline and 1 and 6 months

    Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)

  5. Changes on vertigo symptoms

    Time frame: baseline and 1 and 6 months

    Vertigo is also assessed with the Visual Vertigo Analogue Scale (VVAS)

  6. Difference in blood markers between the two groups

    Time frame: baseline and 1 and 6 months

    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)

  7. Difference in blood markers between the two groups

    Time frame: baseline and 1 and 6 months

    Immunology-related index in the blood sample is superoxide dismutase (SOD)

  8. 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

  1. Differences in Fatigue between the two groups

    Time frame: 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.

  2. Differences in Sleep between the two groups

    Time frame: 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.

  3. Differences in cognition between the two groups

    Time frame: 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.

  4. Differences in executive function between the two groups

    Time frame: 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).

  5. Difference in anxiety between the two groups

    Time frame: baseline and 1 and 6 months

    Anxiety is assessed with Beck Anxiety Inventory (BAI). A higher score corresponding to more severe anxiety symptoms.

  6. Difference in depression between the two groups

    Time frame: 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.

  7. Differences in verbal memory and working memory between the two groups

    Time frame: 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.

  8. Differences in auditory attention between the two groups

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Zhang, PhD

CONTACT

[email protected]

+8618991232265

Yuan Wang, M.D.

CONTACT

[email protected]

0086-13324598144

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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