Behcet DiseaseNCT07135063
Cranial Nerve Functions in Behçet's Disease and Their Relationship With Clinical Parameters
An observational study of Behcet Disease and Cranial Nerve Disorder, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to find out whether cranial nerves are affected in people with Behçet's Disease (BD), and how this might relate to other disease features. Cranial nerves control important functions such as vision, facial movement, hearing, swallowing, and balance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Behcet Disease, Cranial Nerve Disorder
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2025to Sep 2026
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Target Population: Patient Group: Diagnosed Behçet's patients aged 18-75 years Control Group: Age- and gender-matched healthy individuals without neurological, autoimmune, or inflammatory diseases Sample Size: Minimum 30 Behçet patients Minimum 30 healthy controls Recruitment: Participants will be recruited from Marmara University Pendik Research and Education Hospital. Healthy controls will be volunteers among hospital staff and relatives of patients.
Who may be able to join
- Aged 18-75
- Diagnosed with BD according to ACR/EULAR 2013 criteria (patient group)
- Healthy with no relevant medical history (control group)
Who cannot join
- Conditions affecting CN assessment (e.g., facial trauma, surgery, radiotherapy)
- Other rheumatologic or autoimmune diseases
- Psychiatric disorders, alcohol/substance abuse
- Pregnant women
- Use of pacemakers or recent botox to masseter muscle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mehmet Tuncay Duruöz, Professor Doctor contact
Turkey (Türkiye)1 site
Marmara Üniversitesi Tıp Fakültesi
Istanbul, Maltepe, 34854
General Secretary, Secretary, +90 2166254545, prof.tuncayduruoz@gmail.com
About this study
The goal of this study is to find out whether cranial nerves are affected in people with Behçet's Disease (BD), and how this might relate to other disease features. Cranial nerves control important functions such as vision, facial movement, hearing, swallowing, and balance.
The main questions this study will address are:
Read more
- Do people with BD have changes in cranial nerve function compared to healthy individuals?
- Are these changes linked to disease duration, symptoms, or lab results?
Participants will:
- Answer questions about their medical history and BD symptoms
- Complete questionnaires on daily function, mood, and autonomic symptoms
- Have a clinical examination of all 12 cranial nerves
- Undergo non-invasive electrical tests to assess nerve function This study will not involve any medications. All procedures will be completed in one visit.
- Conditions
- Behcet Disease, Cranial Nerve Disorder
- Medical subject headings
- Behcet Syndrome, Cranial Nerve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the presence or absence of cranial nerve involvement in BD.
Upon patient inclusion EMG and clinical examination is carried out
Measured: Once: Upon patient inclusion
Secondary outcomes (1)
Investigate relation between disease duration (months) and cranial nerve involvement in BD patients
Measured: Once: Upon patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135063
- Sponsor's protocol ID
- MarmaraU-FTR-RHZ-01
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Nerve Functions in Behçet's Disease and Their Relationship With Clinical Parameters
- ClinicalTrials.gov ID
- NCT07135063
- Acronym / sponsor ID
- MarmaraU-FTR-RHZ-01
- Conditions
- Behcet Disease, Cranial Nerve Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Aug 2025 (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.
The goal of this study is to find out whether cranial nerves are affected in people with Behçet's Disease (BD), and how this might relate to other disease features. Cranial nerves control important functions such as vision, facial movement, hearing, swallowing, and balance.
The main questions this study will address are:
- Do people with BD have changes in cranial nerve function compared to healthy individuals?
- Are these changes linked to disease duration, symptoms, or lab results?
Participants will:
- Answer questions about their medical history and BD symptoms
- Complete questionnaires on daily function, mood, and autonomic symptoms
- Have a clinical examination of all 12 cranial nerves
- Undergo non-invasive electrical tests to assess nerve function This study will not involve any medications. All procedures will be completed in one visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Target Population: Patient Group: Diagnosed Behçet's patients aged 18-75 years Control Group: Age- and gender-matched healthy individuals without neurological, autoimmune, or inflammatory diseases Sample Size: Minimum 30 Behçet patients Minimum 30 healthy controls Recruitment: Participants will be recruited from Marmara University Pendik Research and Education Hospital. Healthy controls will be volunteers among hospital staff and relatives of patients.
Key inclusion criteria (3 listed)
- Aged 18-75
- Diagnosed with BD according to ACR/EULAR 2013 criteria (patient group)
- Healthy with no relevant medical history (control group)
Key exclusion criteria (5 listed)
- Conditions affecting CN assessment (e.g., facial trauma, surgery, radiotherapy)
- Other rheumatologic or autoimmune diseases
- Psychiatric disorders, alcohol/substance abuse
- Pregnant women
- Use of pacemakers or recent botox to masseter muscle
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
Establish the presence or absence of cranial nerve involvement in BD.
Time frame: Once: Upon patient inclusion
Upon patient inclusion EMG and clinical examination is carried out
1 secondary outcome
Investigate relation between disease duration (months) and cranial nerve involvement in BD patients
Time frame: Once: Upon patient inclusion
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 21 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Mehmet Tuncay Duruöz, Professor Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet Disease and Cranial Nerve Disorder, run by Marmara University at 1 site 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Reihaneh Houshyar Zarnaghi, Assistant Doctor (+90 536 507 3539, h.reihaneh1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the presence or absence of cranial nerve involvement in BD. (time frame: Once: Upon patient inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025.