G51.0
Conditions
Interventions
Group 1: Patients with surgical treatment
Regularly scheduled evaluation of the health status of the denervated M. zygomaticus.
After the baseline evaluation, further clinic visits are scheduled for 4
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Diagnosed denervation of one M. zygomaticus • Anatomic and physiological and mental conditions compatible with the participation in this clinical investigation • High motivation with realistic expectations regarding the participation in this clinical investigation • Signed and dated informed consent before the start of any clinical investigation specific assessment
Exclusion criteria
Exclusion criteria: • Lack of compliance with any inclusion criteria • Pregnant or breast-feeding women • Partial reinnervation of the M. zygomaticus • Other clinical diseases that might result in alteration of the outcomes of this clinical investigation (e.g. muscular and/or skin diseases, epilepsy) • Current participation in other drugs and/or medical device clinical investigations that can affect the results of the present clinical investigation • Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • The duration of denervation • Age, gender, BMI and comorbidities of the patient • Differences in surgical treatments • Adjuvant pharmacological treatments | — |
Primary
| Measure | Time frame |
|---|---|
| Duration until recovery of the M. zygomaticus from the paralysis as measured by EMG. Type of Reinnervation of the M. zygomaticus measured by EMG combined with significant improvements of at least one of the following parameters • Increased M. zygomaticus size confirmed by ultrasound and if available MRI data • Improved facial symmetry • Improved score of the Facial Disability Index (FDI) questionnaire • Improved score Facial Clinimetric Evaluation (FaCE) questionnaire • Improved score of the Sunnybrook Facial Grading System All parameters will be evaluated at the baseline and 4, 6, 8, 12, 16 20 and 52 weeks after the baseline. In addition, FDI and FaCE will also be evaluated after 10 weeks. | — |
Countries
Austria, Germany
Contacts
Public ContactGerd Fabian Volk
Klinik und Poliklinik für Hals-, Nasen- und OhrenheilkundeInstitut für Phoniatrie und Pädaudiologie Universitätsklinikum Jena
Outcome results
None listed