Metabolic Disorders and Vertigo

• Conditions: Meniere Disease; Vestibular Neuritis; Vestibular Migraine; Benign Paroxysmal Positional Vertigo (BPPV); Central Positional Vertigo
• Interventions: Diagnostic Test: diagnostic blood test; Diagnostic Test: neuropsychological test

• Registration Number: NCT04935970
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Also we will analyse another factors (such as anxiety and depression) and optimize therapeuthical approach accordingly with the data.

Detailed Description

Dizziness causes up to 2 to 15% of primary neurological complaints. In some patients who have undergone acute vertigo, postural instability, persistent postural perceptual vertigo (PPPV) develops, while in other similar cases occurs full recovery. So, it is necessary to search for neurophysiological, metabolic and psychophysiological factors and associated premorbid conditions that affect the outcome of neurovestibular compensation.

The case-control study will include 2 groups of patients suffering from vertigo of central and peripherial etiology. First group is recruited with patients were diagnosed with peripherial vestibular disorders, such as benign paroxysmal positional vertigo (BPPV), Meniere disease, vestibular neuritis. The proposal number of subjects in the first group is about forty. The second group will consist of forty patients with central vestibular disfunction: vestibular migraine, central positional vertigo etc. The inclusion of patient with persistent postural perceptual dizziness is discussed. Patients will be tested for hydroxyvitamin D and homocysteine in serum using an enzyme-linked immunosorbent assay (ELISA). The perception of the severity of disability was assessed using the Dizziness scale Handicap Inventory (DHI). All patients will undergo psychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'sscale. Statistical analysis was carried out with the Statistical Analysis System (SAS) package. The relationships will be assessed using the chi squared test and logistic regression. The level of significance is set at p \< 0.05. The methods for small samples (Mann-Whitney U ) will be used. It is presumed that differences in vitamin D levels beetween two groups will be considerable.

Study Timeline

• Study Start: 2019-12-10
• Status Verified: 2021-03
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Primary Completion: 2021-12-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Written informed consent of participation in the study;
• Age:over 18 years old
• complaints of dizziness and insteadiness

Exclusion Criteria

• Severe cognitive impairment (dementia)
• Severe depression
• Syncopal paroxysms
• Epileptic seizures
• Orthostatic hypotension
• Severe arrhythmia, unstable angina pectoris, acute myocardial infarction
• Pregnancy 8. Alcoholism, substance abuse and drug addiction
• Organic liver and kidney diseases with the development of functional disorders.
• Anemia (hemoglobin <10.5 g / dl for women and <11.5 g / dl for men)
• Active oncological process
• Demyelinating and neurodegenerative diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with central vestibular disorder	neuropsychological test	Forty patients vestibular disorder of central origin
patients with central vestibular disorder	diagnostic blood test	Forty patients vestibular disorder of central origin
healthy controls	diagnostic blood test	twenty healthy control without balance problems
patients with peripherial vestibular disorder	diagnostic blood test	Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder
patients with peripherial vestibular disorder	neuropsychological test	Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder

Primary Outcome Measures

Name	Time	Method
hyperhomocysteinaemia reveal	Through 1-6 months of diagnosis established.	enzyme-linked immunosorbent assay (ELISA).
vitamin D deficiency/insufficiency reveal	Through 1-6 months of diagnosis established.	enzyme-linked immunosorbent assay (ELISA).

Secondary Outcome Measures

Name	Time	Method
correlation between metabolic and neuropsychological disorders	through study completion, an average of 1 year	neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.

Trial Locations

Locations (1)

Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University); 🇷🇺 Moscow, Russian Federation