Metabolic Disorders and Vertigo

NCT04935970 | Unknown DMC

• 1 other identifier: 16-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• correlation between metabolic and neuropsychological disorders

  through study completion, an average of 1 year

Study Arms (3)

patients with peripherial vestibular disorder

Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder

Diagnostic Test: diagnostic blood test; Diagnostic Test: neuropsychological test

patients with central vestibular disorder

Forty patients vestibular disorder of central origin

Diagnostic Test: diagnostic blood test; Diagnostic Test: neuropsychological test

healthy controls

twenty healthy control without balance problems

Diagnostic Test: diagnostic blood test

Interventions

diagnostic blood test DIAGNOSTIC_TEST

vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal

healthy controls; patients with central vestibular disorder; patients with peripherial vestibular disorder

neuropsychological test DIAGNOSTIC_TEST

neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.

patients with central vestibular disorder; patients with peripherial vestibular disorder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients from clinic with damage of peripheral and central origin

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

RECRUITING

Related Publications (4)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vestibular Neuronitis; Meniere Disease; Vitamin D Deficiency; Hyperhomocysteinemia

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases; Endolymphatic Hydrops; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Vitamin B Deficiency

Study Officials

• Anna Bedenko, PhD student

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludmila Antonenko, professor

CONTACT

89265774431; luda6917@yandex.ru

Anna Bedenko, PhD student

CONTACT

89164989851; mailanna91@yandex.ru

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: June 23, 2021
• Study Start: December 10, 2019
• Primary Completion: December 30, 2021
• Study Completion: August 31, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)