Cranial Nerve Functions in Behçet's Disease and Their Relationship With Clinical Parameters

NCT07135063 | Not Yet Recruiting

• 1 other identifier: MarmaraU-FTR-RHZ-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Behcet Disease; Cranial Nerve Disorder

Outcome Measures

Primary Outcomes (1)

• Establish the presence or absence of cranial nerve involvement in BD.

  Upon patient inclusion EMG and clinical examination is carried out

  Once: Upon patient inclusion

Secondary Outcomes (1)

• Investigate relation between disease duration (months) and cranial nerve involvement in BD patients

  Once: Upon patient inclusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Aged 18-75
• Diagnosed with BD according to ACR/EULAR 2013 criteria (patient group)
• Healthy with no relevant medical history (control group)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Tıp Fakültesi

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet Syndrome; Cranial Nerve Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Nervous System Diseases

Central Study Contacts

Reihaneh Houshyar Zarnaghi, Assistant Doctor

CONTACT

+90 536 507 3539; h.reihaneh1991@gmail.com

Mehmet Tuncay Duruöz, Professor Doctor

CONTACT

prof.tuncayduruoz@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 21, 2025
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)