Surface electrostimulation for the treatment of M. zygomaticus denervatio
- Conditions
- G51.0Bell palsy
- Registration Number
- DRKS00014860
- Lead Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
• 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.
• 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Significant change in 3 of 6 of the following parameters:<br>• Denervation recovery confirmed by EMG<br>• Increased M. zygomaticus size confirmed by ultrasound and if available MRI data<br>• Improved facial symmetry <br>• Improved score of the Facial Disability Index (FDI) questionnaire<br>• Improved score Facial Clinimetric Evaluation (FaCE) questionnaire<br>• Improved score of the Sunnybrook Facial Grading System <br>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 Outcome Measures
Name Time Method Recording of stimulation parameters<br>Data on Stimulation at home (diary)<br>Demographic data (Age, BMI, gender)<br>Medical history