Evaluation of the therapeutic effects of surface electrostimulation on patients suffering from cervical dystonia

MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 5 人开始时间: 2021年3月1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 CD, independently whether their symptoms improve upon previous Botulin toxin injections, including patients suffering from Torticollis, Laterocollis, Anterocollis, Retrocollis of idiopathic or genetic origin
•The effects of any previous treatments, including but not limited to Botulin toxin injection shall be completely faded at the time of enrolment
•The concomitant presence of neck rotation (rotatory torticollis or rotatocollis), lateral shift, or sagittal shift do not constitute an exclusion criterion
•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
•Primary CD with a neuroepilectic origin
•Secondary CD following the establishment of 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
•Patients who underwent a previous CD surgery
•Patients suffering from segmental, multifocal CD or from the Meige syndrome
•Other clinical conditions that might result in alteration of the outcomes of this clinical investigation
•Use of an active medical implant
•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