Metabolic Disorders and Vertigo
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| ClinicalTrials.gov Identifier: NCT04935970 |
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Recruitment Status : Unknown
Verified March 2021 by I.M. Sechenov First Moscow State Medical University.
Recruitment status was: Recruiting
First Posted : June 23, 2021
Last Update Posted : June 23, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Benign Paroxysmal Positional Vertigo (BPPV) Vestibular Migraine Central Positional Vertigo Vestibular Neuritis Meniere Disease | Diagnostic Test: diagnostic blood test Diagnostic Test: neuropsychological test |
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 |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Other |
| Official Title: | Metabolic Disorders and Their Correction in Vertigo and Unsteadiness |
| Actual Study Start Date : | December 10, 2019 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | August 31, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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patients with peripherial vestibular disorder
Forty patients with BPPV, vestibular neuritis or another peripherial vestibular disorder
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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. |
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patients with central vestibular disorder
Forty patients vestibular disorder of central origin
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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. |
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healthy controls
twenty healthy control without balance problems
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Diagnostic Test: diagnostic blood test
vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal |
- vitamin D deficiency/insufficiency reveal [ Time Frame: Through 1-6 months of diagnosis established. ]enzyme-linked immunosorbent assay (ELISA).
- hyperhomocysteinaemia reveal [ Time Frame: Through 1-6 months of diagnosis established. ]enzyme-linked immunosorbent assay (ELISA).
- correlation between metabolic and neuropsychological disorders [ Time Frame: through study completion, an average of 1 year ]neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04935970
| Contact: Ludmila Antonenko, professor | 89265774431 | luda6917@yandex.ru | |
| Contact: Anna Bedenko, PhD student | 89164989851 | mailanna91@yandex.ru |
| Russian Federation | |
| Clinic of Neurology and Neurosurgery of I.M. Sechenov First Moscow State Medical University (Sechenov University) | Recruiting |
| Moscow, Russian Federation | |
| Contact: Anna Bedenko, PhD student +79164989851 | |
| Principal Investigator: | Anna Bedenko, PhD student | I.M. Sechenov First Moscow State Medical University (Sechenov University) |
Publications of Results:
Other Publications:
| Responsible Party: | I.M. Sechenov First Moscow State Medical University |
| ClinicalTrials.gov Identifier: | NCT04935970 |
| Other Study ID Numbers: |
16-19 |
| First Posted: | June 23, 2021 Key Record Dates |
| Last Update Posted: | June 23, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Benign paroxysmal positional vertigo (BPPV) vestibular neuritis vestibular migraine central positional vertigo |
Meniere disease persistent postural-perceptual dizziness (PPPD) vitamin D deficiency hyperhomocysteinaemia |
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Vertigo Meniere Disease Benign Paroxysmal Positional Vertigo Vestibular Neuronitis Neuritis Metabolic Diseases Dizziness Nervous System Diseases Vestibular Diseases Labyrinth Diseases |
Ear Diseases Otorhinolaryngologic Diseases Neurologic Manifestations Sensation Disorders Peripheral Nervous System Diseases Neuromuscular Diseases Endolymphatic Hydrops Vestibulocochlear Nerve Diseases Retrocochlear Diseases Cranial Nerve Diseases |