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

December 18, 2024 updated by: Murat Akın
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MURAT AKIN, ASSISTANT DOCTOR
  • Phone Number: +905333414438 +90 272 246 33 35
  • Email: makin.md279@gmail.com

Study Contact Backup

  • Name: Orhan Kemal KAHVECİ, PROFESSOR
  • Phone Number: +905324713283 +90 272 246 33 35
  • Email: orhangs75@hotmail.com

Study Locations

  • Turkey
      • Afyonkarahisar, Turkey
        • Active, not recruiting
        • Afyonkarahisar Health Sciences University
      • Afyonkarahisar, Turkey
        • Recruiting
        • Afyonkarahisar Health Sciences University
        • Contact:
        • Contact:
        • Contact:
          • Orhan K KAHVECİ, PROFESSOR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Bell palsy patient group
Patients who applied to our hospital due to idiopathic facial paralysis within the first month
control group
Healthy individuals with no known health problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homosystein test results
Time Frame: up to 24 weeks
The results have not been obtained from lab yet. So none results were measured .
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murat Akın

Investigators

  • Principal Investigator: Orhan Kemal KAHVECİ, PROFESSOR, AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

August 4, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSÜ-KBB-MA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

WILL BE DECLARED AT THE RESULT OF THE STUDY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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