Improvement of the severity of peripheral facial nerve palsy by surface electrical stimulation quantified with established and euclidean ratings

MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 11 人开始时间: 2021年10月28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 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.

•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

发起方

MED-EL Elektromedizinische Geräte GmbH