Neurodevice Phase I: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.
研究概览
简要总结
This study aims to evaluate the safety of a wireless implantable neurodevice microsystem in tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of neural activities and the successful control of an external device.
详细描述
The goal of this study is to develop a miniaturized wireless implantable neurodevice microsystem that records and transmits signals from the motor cortex of tetraplegic patients, bypassing the damaged nervous tissue, to control an external assistive device that restores some form of independence to patients in terms of communication or mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years old and older
- •Tetraparesis
- •Written informed consent obtained from the patient or legal representative (in the event where the patient is unable to provide consent) prior to entry into the study in accordance with local EC/IRB regulations and/or other application regulations for surrogate consent.
- •Able to perform the pre-operation Brain Computer Interface training as judged by the research team.
排除标准
- •Significant medical co-morbidities e.g. cardiac disease
- •Bleeding disorders
- •Any contraindication to surgery
- •Other concomitant intracranial pathologies
- •History of seizures or epilepsy disorder
- •Complications of coagulopathy
- •Surgically unfit
- •Significant psychological issues e.g. Depression
- •Poor psychological support
- •No means of communication
- •Any disease, in the opinion of the Investigator, that is unstable or which could jeopardise the safety of the patient
- •If applicable, psychological assessment may be performed prior to selection as the implantation process will be a long a stressful event, requiring a significant degree of patient cooperation and resilience.
结局指标
主要结局
The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.
时间窗: 6 months post-implant
The primary objective of this study is to determine the safety of the device. This will be assessed based on the number of SAEs and AEs reported for each patient during the 12 months post-implantation evaluation. This measure will considered a success if the device is not removed for safety reasons within 12-months after implantation.
次要结局
- Number of successful trials per session(Day 1 to Day 365 post-implant)
- Decoding accuracy per training session.(Day 1 to Day 365 post-implant)
- The signal quality of the electrodes for long-term recording of neural signals.(Day 1 to Day 365 post-implant)
- Time taken to complete each trial per session(Day 1 to Day 365 post-implant)