G51.0
Conditions
Interventions
Group 1: Patients with peripheral facial paralysis with electrical stimulation
Group 2: Patients with peripheral facial paralysis without electrical stimulation (historical)
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 the zygomaticus on one side - Anatomically and physiologically compatible with the criteria for participation in the clinical trial - Mentally and physically able to use the external stimulator independently at home apply - High motivation combined with realistic expectations regarding the Participation in the clinical trial. - Signed and dated patient information and declaration of consent before carrying out any procedures relevant to the examination.
Exclusion criteria
Exclusion criteria: Lack of compliance with any inclusion criteria - Pregnant or breastfeeding women - Partial reinnervation of the zygomaticus muscle - Any conservative treatment method (e.g. injections with botulinum toxin and / or wrinkle injection) in the face and head area or physical therapy measures to treat denervation of the zygomaticus muscle in the last 3 months prior to inclusion in this clinical trial - Any prior surgical treatment for symptoms of denervation of the zygomaticus muscle - Other clinical conditions affecting the results of this clinical trial could influence (general muscle diseases; epilepsy; skin diseases) - Carrier of an active medical implant - Known allergies or intolerances to materials used in used in clinical trials. - Simultaneous participation in other drug or medical device studies, that could affect the results of this clinical trial - Anything in the opinion of the investigator puts the patient at increased risk could expose, or compromise patient compliance could or what a successful completion of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of an improvement in the muscle tone of the face based on the ratings and by measuring the photos | — |
Secondary
| Measure | Time frame |
|---|---|
| Proof of reinnervation of the facial muscles based on the ratings and by measuring the photos | — |
Countries
Germany
Contacts
Public ContactGerd Fabian Volk
Fazialis-Nerv-Zentrum JenaKlinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum Jena
Outcome results
None listed