Surface electrostimulation for the treatment of M. zygomaticus denervation

MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 15 人开始时间: 2018年6月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•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.

发起方

MED-EL Elektromedizinische Geräte GmbH