Facial Paralysis, PeripheralNCT06742580
The Relationship Between Idiopathic Acute Peripheral Facial Paralysis and Homocysteine Level in Adult Patients
An observational study of Facial Paralysis, Peripheral and Bell Palsy, run by Murat Akın at 3 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Paralysis, Peripheral, Bell Palsy
- How many people
- 80 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 4 Aug 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL
Who may be able to join
- Patients admitted with acute facial paralysis
Who cannot join
- Facial and ear trauma or tumor
- İatrogenic
- Cholesteatoma
- Facial paralysis due to central nervous system diseases
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 2 recruiting
- Active, not recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar
Murat AKIN, ASSISTANT DOCTOR, 905333414438, makin.md279@gmail.com
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar
Murat AKIN, ASSISTANT DOCTOR, 905333414438, makin.md279@gmail.com
Orhan K Kahveci, Professor, 905324713283, orhangs75@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Facial Paralysis, Peripheral, Bell Palsy
- Keywords
- Acute Peripheral Facial Paralysis, Homocysteine, Bell Palsy
- Medical subject headings
- Facial Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Homosystein test results
The results have not been obtained from lab yet. So none results were measured .
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Dec 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion4 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Facial Paralysis, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Murat Akın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murat Akın, Afyonkarahisar Health Sciences University
- Investigators
- Orhan Kemal KAHVECİ, PROFESSOR, Principal investigator, AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742580
- Sponsor's protocol ID
- AFSÜ-KBB-MA-01
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: WILL BE DECLARED AT THE RESULT OF THE STUDY
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.
PubMed 36397921Son 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/
PubMed 32119295Niu 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.
PubMed 36658368Eviston 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.
PubMed 25857657
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Idiopathic Acute Peripheral Facial Paralysis and Homocysteine Level in Adult Patients
- ClinicalTrials.gov ID
- NCT06742580
- Acronym / sponsor ID
- AFSÜ-KBB-MA-01
- Conditions
- Facial Paralysis, Peripheral, Bell Palsy
- Keywords
- Acute Peripheral Facial Paralysis, Homocysteine, Bell Palsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Murat AkınUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 4 Aug 2025 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL
Key inclusion criteria (1 listed)
- Patients admitted with acute facial paralysis
Key exclusion criteria (4 listed)
- Facial and ear trauma or tumor
- İatrogenic
- Cholesteatoma
- Facial paralysis due to central nervous system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Homosystein test results
Time frame: up to 24 weeks
The results have not been obtained from lab yet. So none results were measured .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 36397921Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
- Background: PubMed 32119295Son 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/
- Background: PubMed 36658368Niu 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.
- Background: PubMed 25857657Eviston 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.
- Individual participant dataSharing planned: No. WILL BE DECLARED AT THE RESULT OF THE STUDY
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Orhan Kemal KAHVECİ, PROFESSOR principal investigator
AFYON HEALTH SCIENCES UNIVERSITY HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Paralysis, Peripheral and Bell Palsy, run by Murat Akın at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MURAT AKIN, ASSISTANT DOCTOR (+90 272 246 33 35 ext. +905333414438, makin.md279@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homosystein test results (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742580, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.