Metabolic Disorders and Vertigo

Metabolic Disorders and Their Correction in Vertigo and Unsteadiness

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibular Migraine; Meniere Disease; Vestibular Neuritis; Benign Paroxysmal Positional Vertigo (BPPV); Central Positional Vertigo
• Intervention / Treatment: Diagnostic test: diagnostic blood test; Diagnostic test: neuropsychological test

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ludmila Antonenko, professor; Phone Number: 89265774431; Email: luda6917@yandex.ru
• Study Contact Backup: Name: Anna Bedenko, PhD student; Phone Number: 89164989851; Email: mailanna91@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University)
    • Contact: Anna Bedenko, PhD student; Phone Number: +79164989851

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients from clinic with damage of peripheral and central origin

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with peripherial vestibular disorder; Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder	Diagnostic test: diagnostic blood test; vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal; Diagnostic test: neuropsychological test; neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
patients with central vestibular disorder; Forty patients vestibular disorder of central origin	Diagnostic test: diagnostic blood test; vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal; Diagnostic test: neuropsychological test; neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
healthy controls; twenty healthy control without balance problems	Diagnostic test: diagnostic blood test; vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Anna Bedenko, PhD student, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

General Publications

• Bedenko A.S., Antonenko L.М., Barinov A.N. Metabolic disorders in the pathogenesis of various causes of dizziness and instability // Annals of the Russian academy of medical sciences. - 2020. - Vol. 75. - N. 6. - P. 605-608. doi: 10.15690/vramn1244
• Bedenko A.S. Vertigo in neurological practice: rare causes and difficult decisions. Medical alphabet. 2019;2(19):34-36. (In Russ.) https://doi.org/10.33667/2078-5631-2019-2-19(394)-34-36
• Bedenko A.S. Metabolic factors in pathogenesis of migraine and unsteadiness. Medical alphabet. 2020;(33):18-20. (In Russ.) https://doi.org/10.33667/2078-5631-2020-33-18-20
• Bedenko A.S. Vertigo caused by vestibular migraine: current problems of pathogenesis, diagnostics and therapy. Epilepsy and paroxysmal conditions. 2020;12(3):177-181. (In Russ.)https://doi.org/10.17749/2077-8333/epi.par.con.2020.032

Helpful Links

• list of publications

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: vitamin D deficiency; vestibular neuritis; Benign paroxysmal positional vertigo (BPPV); vestibular migraine; central positional vertigo; Meniere disease; persistent postural-perceptual dizziness (PPPD); hyperhomocysteinaemia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Otorhinolaryngologic Diseases; Peripheral Nervous System Diseases; Labyrinth Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibular Diseases; Sensation Disorders; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Endolymphatic Hydrops; Neuritis; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness; Metabolic Diseases; Vestibular Neuronitis; Meniere Disease
• Other Study ID Numbers: 16-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I give my consent to provide actual study protocol. However, It is impossible to provide stastistical documents and primary patient's documentation (It is forbidden by Local Ethic Committee of Sechenov University)

Drug and device information, study documents

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