Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV
Disqualifiers
History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Simultaneous cortico-spinal magnetic resonance imaging, Serum
DeviceSimultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: BPPV patients1 intervention
Group B: Healthy controls1 intervention
Trial outcomes
Primary outcomes
1
Differences between patients with BPPV and control group in brain structure
The changes of brain volume (mm3) are evaluated by structural MRI
Time frame
baseline and 1 and 6 months2
Differences between two groups in brain function
The changes of brain functional connectivity intensity are evaluated by functional MRI
Time frame
baseline and 1 and 6 months3
Changes on vertigo symptoms
Vertigo is assessed with the Dizziness Handicap Inventory (DHI Scale)
Time frame
baseline and 1 and 6 months4
Changes on vertigo symptoms
Vertigo is also assessed with the Activities-specific Balance Confidence Scale (ABC Scale)
Time frame
baseline and 1 and 6 monthsSecondary outcomes
1
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.
Time frame
baseline and 1 and 6 months2
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.
Time frame
baseline and 1 and 6 months3
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.
Time frame
baseline and 1 and 6 months4
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).
Time frame
baseline and 1 and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov