Facial palsy: current protocols for the diagnosis, treatment and follow-up of patients in Germany and in Austria

Recruiting

Conditions: Bell palsy
G51.0

Registration Number: DRKS00022309

Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

• Documented diagnosis of facial palsy
• Signed and dated informed consent before the start of any registry-specific procedures for subjects recruited prospectively

Exclusion Criteria

• Lack of compliance with any inclusion criteria
• Other clinical diseases that might result in alteration of the outcomes of this registry (e.g. neuromuscular diseases)
• Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the registry

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following information is collected at the beginning of the inclusion of a subject:<br>•Facial palsy etiology and history<br>•Age<br>•Gender<br>The following information /test results are collected for the entire duration of the registry, whenever they are available:<br>•Demographic<br>•Medical history<br>•Medication history<br>•Facial palsy history<br>•Facial palsy treatment record<br>•Videos (e.g. 3D videos)<br>•Photos (e.g. 3D photos)<br>•Ultrasound<br>•MRI<br>•CT scans<br>•EMD<br>•Sunnybrook<br>•Questionnaires:<br>•FDI<br>•FaCE<br>•GBI

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is to evaluate the effects of the chosen treatment by comparing the results of the tests performed at the initial visit, with those of the last follow-up visit within 5 years of treatment. Stratification will be based on the type of treatment method chosen.