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

NCT ID: NCT06742580

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-08-04

Brief Summary

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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

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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.

Conditions

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Facial Paralysis, Peripheral Bell Palsy

Keywords

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Acute Peripheral Facial Paralysis Homocysteine Bell Palsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bell palsy patient group

Patients who applied to our hospital due to idiopathic facial paralysis within the first month

No interventions assigned to this group

control group

Healthy individuals with no known health problems

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Murat Akın

OTHER

Sponsor Role lead

Responsible Party

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Murat Akın

assistant doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Orhan Kemal KAHVECİ, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL

Locations

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Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status RECRUITING

Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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MURAT AKIN, ASSISTANT DOCTOR

Role: CONTACT

Phone: +90 272 246 33 35

Email: [email protected]

Orhan Kemal KAHVECİ, PROFESSOR

Role: CONTACT

Phone: +90 272 246 33 35

Email: [email protected]

Facility Contacts

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Murat AKIN, ASSISTANT DOCTOR

Role: primary

Murat AKIN, ASSISTANT DOCTOR

Role: primary

Orhan K Kahveci, Professor

Role: backup

Orhan K KAHVECİ, PROFESSOR

Role: backup

References

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Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.

Reference Type BACKGROUND
PMID: 36397921 (View on PubMed)

Son P, Lewis L. Hyperhomocysteinemia. 2022 May 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554408/

Reference Type BACKGROUND
PMID: 32119295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36658368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25857657 (View on PubMed)

Other Identifiers

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AFSÜ-KBB-MA-01

Identifier Type: -

Identifier Source: org_study_id