Clinical trial NCT04935970: Metabolic Disorders and Vertigo
Official title: Metabolic Disorders and Their Correction in Vertigo and Unsteadiness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
Vestibular Migraine
Central Positional Vertigo
Vestibular Neuritis
Meniere Disease
Keywords: Benign paroxysmal positional vertigo (BPPV)
vestibular neuritis
vestibular migraine
central positional vertigo
Meniere disease
persistent postural-perceptual dizziness (PPPD)
vitamin D deficiency
hyperhomocysteinaemia
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from clinic with damage of peripheral and central origin

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.

Eligibility criteria: 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.

Primary outcomes:
measure: vitamin D deficiency/insufficiency reveal
timeFrame: Through 1-6 months of diagnosis established.
measure: hyperhomocysteinaemia reveal
timeFrame: Through 1-6 months of diagnosis established.
Secondary outcomes:
measure: correlation between metabolic and neuropsychological disorders
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Anna Bedenko, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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
citation: 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
citation: 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