Exploring the effects of surface electrostimulation toimprove the voice quality of patients suffering fromspasmodic dysphonia and/or voice tremor

MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 40 人开始时间: 2020年11月4日最近更新: 2024年8月19日

适应症

试验速览

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•Age = 18 years
•- Patients diagnosed with adductory or abductory SD, and/or voice tremor, independently whether their symptoms improve upon previous Botulin injections
•- The effects of any previous treatments, including but not limited to Botulin injection shall be completely faded at the time of the first stimulation
•- Aging voice, cervical dystonia, supraglottal hyperactivity, or glottal hypoactivity do not constitute an exclusion criterion for the enrollment in this study as long as correctly and accurately described
•- Signed and dated informed consent before the start of any clinical investigationspecific procedure for all the recruited subjects

•- Lack of compliance with any inclusion criteria
•- Pregnant or breast-feeding women
•- Patients for whom the previous treatment is still effective at the time of enrolment
•- Patients who underwent a permanent laryngeal surgery
•- Patients with chronic upper airway infections or severe respiratory diseases (e.g. Chronic Obstructive Pulmonary Disease (COPD) grade II or higher)
•- Other clinical conditions that might result in alteration of the outcomes of this clinical investigation other than those listed in the inclusion criteria
•- 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 2020CIP004
•- 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