Metabolic Disorders and Vertigo

Meniere Disease Clinical Trial

Official title:

Metabolic Disorders and Their Correction in Vertigo and Unsteadiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04935970
• Other study ID #: 16-19
• Status: Recruiting
• Start date: December 10, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Ludmila Antonenko, professor
• Phone: 89265774431
• Email: luda6917[@]yandex.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Benign Paroxysmal Positional Vertigo (BPPV)
• Dizziness
• Meniere Disease
• Metabolic Diseases
• Neuritis
• Vertigo
• Vestibular Migraine
• Vestibular Neuritis
• Vestibular Neuronitis

Intervention

Diagnostic Test:
• diagnostic blood test
vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal
• neuropsychological test
neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.

Locations

Country	Name	City	State
Russian Federation	Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

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

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., Antonenko L.?., 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin D deficiency/insufficiency reveal	enzyme-linked immunosorbent assay (ELISA).	Through 1-6 months of diagnosis established.
Primary	hyperhomocysteinaemia reveal	enzyme-linked immunosorbent assay (ELISA).	Through 1-6 months of diagnosis established.
Secondary	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

External Links

•   list of publications