G51.0
Conditions
Interventions
Group 1: For this study the following procedures will be performed during a single session:
Regular EMG of the target muscles to verify the diagnosis and subsequent electrostimulation of the facial ne
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 18 years - Diagnosed facial palsy with aberrant reinnervation of the M. zygomaticus and/or the M. orbicularis oculi - Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation - 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 - Any - 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 - physiotherapeutic treatment during the last 3 month prior to inclusion in this clinical investigation - previous surgical treatment 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 |
|---|---|
| The following data is produced and evaluated for this study in the course of a single session: - Videos will be recorded of the target and the contralateral muscles at rest; in response to facial mimic without stimulation and in response to selective electrostimulation of the targeted muscles - The applied stimulation parameters are recorded | — |
Secondary
| Measure | Time frame |
|---|---|
| The following additional data is produced and evaluated for this study in the course of a single session: - EMG measurements to confirm the degree of aberrant reinnervation - Sunnybrook Facial Grading System - Demographic data - Adverse events | — |
Countries
Germany
Contacts
Public ContactOrlando Guntinas-Lichius
Universitätsklinikum Jena
Outcome results
None listed