Use of Nexstim SNBT System in Its Intended Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Assessment of usability of the graphical user interface for use of the device in its intended use
研究概览
简要总结
The clinical investigation assesses the usability of the new graphical user interface of the Nexstim SNBT device in its intended clinical uses. The hardware and the technical functionality of the device of the SNBT device are in other respects similar to those of the earlier Nexstim NBT device, which has been cleared by FDA for treatment of Major Depressive Disorder in 2017 (K170902) and has received EU CE mark for the same and for treatment of chronic neuropathic pain.
The present investigation is not intended to establish the safety and efficacy of the SNBT device. Rather, the purpose is to assess the usability of the new user interface in a feasibility study conducted with a prototype device utilizing the new user interface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-64 years signed informed consent form
排除标准
- •pregnant implanted electrical device ferromagnetic metal anywhere in the body metal in head except amalgam dental fillings epilepsy migraine previous head trauma or surgery a diagnosed neurological disorder medication affecting the central nervous system
结局指标
主要结局
Assessment of usability of the graphical user interface for use of the device in its intended use
时间窗: Up to 3 months. From subject's enrollment to end of subject's study participation.
yes/no assessment by an expert clinical user of the technology
次要结局
- Assessment of usability of the graphical user interface for use for motor threshold determination by device use(Up to 3 months. From subject's enrollment to end of subject's study participation.)
- Assessment of usability of the graphical user interface for use for motor cortex localization by device use(Up to 3 months. From subject's enrollment to end of subject's study participation.)
- Assessment of usability of the graphical user interface for the targeting of the intracranial electric field generated by the device to the intracranial target location required for the use of the device in its intended use(Up to 3 months. From subject's enrollment to end of subject's study participation.)
- Assessment of whether the usability of the graphical user interface is superior to that experienced by the user during his/her previous experience with earlier NBT product generations(Up to 3 months. From subject's enrollment to end of subject's study participation.)