G51.0
Conditions
Interventions
Group 1: Electrostimulation of the M. zygomaticus with surface electrodes
Stimulation parameter that are used will be determined individually for each patient and will remain within the following rang
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 mental conditions compatible with the participation in this clinical investigation • Mental and physical condition compatible with the self-training at home with the external stimulator • High motivation with realistic expectations regarding the participation in this clinical in-vestigation • 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 at baseline visit • Any o conservative treatment (e.g. injection with botulinum toxin and/or wrinkle treatment by injection) during the last 3 month prior to inclusion in this clinical investigation o physiotherapeutic treatment during the last 3 month prior to inclusion in this clinical investigation o previous surgical treatment employed to treat the denervation of the M. zygomaticus, which, according to the opinion of the investigator may influence the outcomes of this study and the effect of which cannot be separated from the effects of the electrostimulation. • Other clinical diseases that might result in alteration of the outcomes of this clinical investigation (e.g. muscular and/or skin diseases, epilepsy) • Use of an active medical implant • Known allergies or intolerance to the material used for this clinical investigation • 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
Primary
| Measure | Time frame |
|---|---|
| Significant change in 3 of 6 of the following parameters: • Denervation recovery confirmed by EMG • 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, 28, 40 and 52 weeks after the baseline. In addition, FDI and FaCE will also be evaluated after 2 and 10 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recording of stimulation parameters Data on Stimulation at home (diary) Demographic data (Age, BMI, gender) Medical history | — |
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