A clinically integrated, frameless human Neuropixels workflow

Area of Science:

• Neuroscience
• Medical Technology
• Clinical Research

Background:

• High-density electrophysiological recording with Neuropixels probes offers single-unit resolution of human neural activity.
• Integration into clinical environments and broader accessibility remain significant challenges, with limited prior recordings in the US.

Purpose of the Study:

• To present a reproducible roadmap for human Neuropixels recordings within the United Kingdom's regulatory framework.
• To establish and evaluate a frameless intraoperative workflow for clinical Neuropixels recordings.

Main Methods:

• Utilized the IDEAL Stage 2a (Development) framework for workflow establishment.
• Employed manufacturer-sterilized probes and a commercially available, clinical-grade setup for frameless intraoperative recording.
• Prospectively evaluated the workflow in six participants undergoing ventriculoperitoneal shunt surgery, assessing safety, timing, and data yield.

Main Results:

• Achieved zero research-related adverse events, demonstrating clinical safety.
• Maintained a procedural extension of approximately 30 minutes.
• Successfully resolved technical barriers like neuronavigation interference and hardware instability through iterative mitigation.
• Progressively increased single-unit yield to a maximum of 146 manually curated units.

Conclusions:

• The developed workflow provides a reproducible and clinically safe method for human Neuropixels recordings in the UK.
• This roadmap facilitates the integration of high-density electrophysiology into routine clinical environments.
• The study demonstrates the feasibility of obtaining high-quality neural data in a nationally managed regulatory setting.