Evaluation of the therapeutic effects of surface electrostimulation on patients suffering from blepharospasm

MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 5 人开始时间: 2021年2月18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
•- Patients diagnosed with focal, primary bilateral BEB, independently whether their symptoms improve upon previous Botulin toxin injections
•- The effects of any previous treatments, including but not limited to Botulin toxin injection shall be completely faded at the time of enrolment
•- Patients who developed anti-BTX antibodies are not excluded
•- Signed and dated informed consent before the start of any clinical investigation-specific procedure for all the recruited subjects

•- Lack of compliance with any inclusion criteria
•- Secondary BEB
•- Unilateral BEB
•- Lesion of the N. oculomotorius or of any other facial nerves
•- Patients suffering from neurodegenerative diseases
•- Suffering from depression equivalent to a score of = 20 according to the Beck Depression Inventory (BDI)
•- Suffering from psychological and or psychiatric diseases
•- Pregnant or breast-feeding women
•- DBS users
•- Use of an active medical implant
•- Patients who underwent a previous BEB-related surgery
•- Patients suffering from hemi-facial spasm, segmental, multifocal CD or from the Meige syndrome
•- Other clinical conditions that might result in alteration of the outcomes of this clinical investigation
•- Known allergies or intolerance to the material used for this clinical investigation
•- Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the 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