The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Background SNR pre-resection recording
研究概览
简要总结
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.
Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of enrolment
- •Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)
- •Provided informed consent for study participation by the subject
排除标准
- •Occipital lesion
- •Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.
- •Planned ioECoG recordings during fully awake surgery and/or functional recordings
- •Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
- •Active participation in another investigational device study
- •Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
- •Insufficient understanding of Dutch language.
结局指标
主要结局
Background SNR pre-resection recording
时间窗: up to 24 hours
Performance in terms of signal quality is assessed via background signal to noise ratio (SNR). Only channels which record properly based on visual inspection (no noise, no flat line) will be included in the background SNR calculation. For the pre-resection recordings (SITUATION I/I\*), the background SNR per (included) channel and the average SNR for the electrode grid will be calculated, and pairwise comparison will be conducted between TD (SITUATION I\*) and CD (SITUATION I).
次要结局
- Epileptic biomarker identification ( eg. number of spikes/HFOs per min, event SNR)(up to 24 hours)
- Electrode deficiency ratio (%)(up to 24 hours)
- Background SNR of post-resection recordings(up to 24 hours)
- Surgical complications (e.g. SAEs/SADEs)(up to hospital discharge, on average at 10 days)
- Usability evaluation(up to 48 hours)