An observational study in Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Migraine and Central Positional Vertigo, sponsored by I.M. Sechenov First Moscow State Medical University. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-23.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
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.
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.
75 studies on the registry are indexed under Benign Paroxysmal Positional Vertigo; 15 are open to participants now.
This study's planned enrollment of 100 is close to the median of 104 across 11 observational studies indexed under Benign Paroxysmal Positional Vertigo.
Browse Benign Paroxysmal Positional Vertigo studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients from clinic with damage of peripheral and central origin
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder
Diagnostic Test: diagnostic blood test · Diagnostic Test: neuropsychological test
Forty patients vestibular disorder of central origin
Diagnostic Test: diagnostic blood test · Diagnostic Test: neuropsychological test
twenty healthy control without balance problems
Diagnostic Test: diagnostic blood test
vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal
neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
vitamin D deficiency/insufficiency reveal
enzyme-linked immunosorbent assay (ELISA).
Time frame: Through 1-6 months of diagnosis established.
hyperhomocysteinaemia reveal
enzyme-linked immunosorbent assay (ELISA).
Time frame: Through 1-6 months of diagnosis established.
correlation between metabolic and neuropsychological disorders
neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
Time frame: through study completion, an average of 1 year
Plan to share: No — 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)
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Benign Paroxysmal Positional Vertigo →
I.M. Sechenov First Moscow State Medical University →