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Recruiting NCT06742580

The Relationship Between Idiopathic Acute Peripheral Facial Paralysis and Homocysteine Level in Adult Patients

Observational Facial Paralysis, Peripheral Bell Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Facial Paralysis, Peripheral, Bell Palsy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

In the etıology of Idıopathıc Acute Perıpheral Facıal Palsy, known as bell palsy, many causes have been descrıbed, such as specıfıc ımmune, ıchemıc, ınfectıous and heredıal factors. ın our study, we have observed the blood homocysteıne level that causes thrombotıc dısorders ın paralysıs patıents.

Detailed description

Bell's palsy, also known as "acute facial palsy of unknown cause", is a common cranial neuropathy that characteristically causes facial muscle paresis or complete paralysis on one side, occurs suddenly and may progress over 48 hours. It is accompanied by postauricular pain, dysgeusia, subjective alteration of facial sensation, and hyperacusis. Bell's palsy accounts for 60-75 percent of all cases of facial palsy. It occurs in 7-40 cases per 100,000 people each year, and the prevalence is similar in both sexes. Its cause remains idiopathic, but it is strongly associated with certain viral infections, which cause neuritis leading to focal edema, demyelination, and ischemia. Although the exact pathogenesis of Bell's palsy is unknown and is considered idiopathic, specific immune, ischemic, and hereditary factors are strongly associated with its etiology. Homocysteine is an amino acid that is not provided by the diet and can be converted to cysteine with the help of specific B vitamins or converted back to methionine, an essential amino acid. Homocysteine levels vary between men and women and are usually in the normal range of 5 to 15 micromoles/L. When homocysteine levels exceed 15 micromoles/L, it is called hyperhomocysteinemia.

The estimated prevalence of mild hyperhomocysteinemia in the general population is 5% to 7%. Several studies have shown that it is an independent risk factor for thrombotic disorders (i.e., deep vein thrombosis). It has even been reported that lowering a patient's homocysteine level by 25% reduces the risk of stroke by 19%.

A significant relationship was found in the meta-analysis conducted in the literature regarding sudden sensorineural hearing loss and high homocysteine levels. Due to the similar anatomical location of the facial nerve and N. vestibulocochlearis, it was planned to examine the relationship between acute idiopathic peripheral paralysis and homocysteine. There is no previous study in the literature. Therefore, this study will be the pioneering research in the literature regarding blood homocysteine levels in patients diagnosed with Idiopathic Acute Peripheral Facial Paralysis.

Primary outcome measures

  • Homosystein test results [Time frame: up to 24 weeks]

Eligibility criteria

Inclusion criteria

\- Patients admitted with acute facial paralysis

Exclusion criteria

  • Facial and ear trauma or tumor
  • İatrogenic
  • Cholesteatoma
  • Facial paralysis due to central nervous system diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 3 centers
  • Afyonkarahisar Health Sciences University — Afyonkarahisar
  • Afyonkarahisar Health Sciences University — Afyonkarahisar
  • Afyonkarahisar Health Sciences University — Afyonkarahisar

Publications

  • Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct. PMID 36397921
  • Son P, Lewis L. Hyperhomocysteinemia. 2022 May 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554408/ PMID 32119295
  • Niu X, Chen Y, Zhong Y, Xiao X. The relationship between serum homocysteine levels and sudden sensorineural hearing loss: a meta-analysis. Eur Arch Otorhinolaryngol. 2023 May;280(5):2091-2097. doi: 10.1007/s00405-023-07829-w. Epub 2023 Jan 19. PMID 36658368
  • Eviston TJ, Croxson GR, Kennedy PG, Hadlock T, Krishnan AV. Bell's palsy: aetiology, clinical features and multidisciplinary care. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1356-61. doi: 10.1136/jnnp-2014-309563. Epub 2015 Apr 9. PMID 25857657

Identifiers

NCT: NCT06742580 · AFSÜ-KBB-MA-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗