Neuropixels are silicon-based electrophysiology-recording probes with high channel count and recording-site density. These probes offer a turnkey platform for measuring neural activity with single-cell resolution and at a scale that is beyond the capabilities of current clinically approved devices. Our team demonstrated the first-in-human use of these probes during resection surgery for epilepsy or tumors and deep brain stimulation electrode placement in patients with Parkinson’s disease. Here, we provide a better understanding of the capabilities and challenges of using Neuropixels as a research tool to study human neurophysiology, with the hope that this information may inform future efforts toward regulatory approval of Neuropixels probes as research devices. In perioperative procedures, the major concerns are the initial sterility of the device, maintaining a sterile field during surgery, having multiple referencing and grounding schemes available to de-noise recordings (if necessary), protecting the silicon probe from accidental contact before insertion and obtaining high-quality action potential and local field potential recordings. The research team ensures that the device is fully operational while coordinating with the surgical team to remove sources of electrical noise that could otherwise substantially affect the signals recorded by the sensitive hardware. Prior preparation using the equipment and training in human clinical research and working in operating rooms maximize effective communication within and between the teams, ensuring high recording quality and minimizing the time added to the surgery. The perioperative procedure requires ~4 h, and the entire protocol requires multiple weeks.

Neuropixel 是硅基电生理学记录探针，具有高通道数和记录位点密度。这些探针提供了一个交钥匙平台，用于以单细胞分辨率测量神经活动，其规模超出了当前临床批准的设备的能力。我们的团队展示了这些探针在癫痫或肿瘤切除手术以及帕金森病患者深部脑刺激电极放置过程中首次在人体中的使用。在这里，我们更好地了解使用 Neuropixels 作为研究人类神经生理学的研究工具的能力和挑战，希望这些信息可以为未来监管部门批准 Neuropixels 探针作为研究设备的努力提供信息。在围手术期手术中，主要关注的是设备的初始无菌、在手术期间保持无菌区域、具有可用于降噪记录的多个参考和接地方案（如有必要）、在插入和获取之前保护硅探针免遭意外接触。高质量的动作电位和局部场电位记录。研究团队确保设备完全运行，同时与手术团队协调消除电噪声源，否则可能会严重影响敏感硬件记录的信号。使用设备进行事先准备，进行人体临床研究培训，并在手术室工作，最大限度地提高团队内部和团队之间的有效沟通，确保高记录质量并最大限度地减少手术时间。围手术期大约需要 4 小时，整个方案需要数周。