NCT05041114撤回不适用
Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment.
Synchron Medical, Inc.4 个研究点 分布在 1 个国家开始时间: 2022年4月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Treatment related adverse events
研究概览
简要总结
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.
The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe motor impairment
- •Able to give consent
- •Appropriate candidate for neurointerventional procedure
- •Able and willing to access all clinical testing and not impeded by geographical location
- •Proficient in English
- •Have a study partner
排除标准
- •Active condition resulting in immunosuppression
- •Unsuitable for general anaesthetic
- •Anaphylactic allergy to contrast media
- •Allergy to nickel
- •History of pulmonary embolism
- •History of recent deep vein thrombosis
- •Psychiatric or psychological disorder
- •No study partner or caregiver
- •Unable to provide evidence of COVID vaccination
结局指标
主要结局
Treatment related adverse events
时间窗: 12 months post implant
次要结局
未报告次要终点
研究者
研究点 (4)
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