DRKS00023523招募中1 期
ni- or bilateral electrostimulation of the lateral cricoarytenoid muscle (LCA) to improve the voice quality of patients suffering from spasmodic dysphonia and/or voice tremor
MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 80 人开始时间: 2020年11月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years
- •- Patients diagnosed with adductory or abductory SD, and/or voice tremor, 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 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
排除标准
- •- 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. 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
- •- Patients on anticoagulation, on ASA therapy and/or with coagulation disorder
- •- 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
研究者
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