Electrocorticography as a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow.
研究概览
简要总结
A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments.
Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.
排除标准
- •Patients without capacity to give consent at time of recruitment
结局指标
主要结局
Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow.
时间窗: Over a 28 month period from November 2022 to March 2026
The primary outcome is to report the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow based upon analysing prospective data including qualitative questionnaires administered to surgeons and scrub nurses, anonymised clinical data, and anonymised electrophysiological data. The primary outcome is to produce a descriptive report of the electrophysiological data recorded and the challenges encountered in the delivery of the novel electrophysiological recording for patients undergoing planned neurosurgical procedures at the National Hospital for Neurology and Neurosurgery, London.
次要结局
- Analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction.(Over a 28 month period from November 2022 to March 2026)