#51 | Empowering Autonomy in the ALS Community: Translation of the Layer 7 Minimally Invasive Brain-Computer Interface

Larsen, E. K., Makhfi, H., Barth, K., Srivastava, A., Ghorpade, E., Berkowitz, J., Miller, J. S., Ho, E., Claudi, F., Lucas, M., Dister, J., Pinto, V., Strauss, J., Mermel, C., & Rapoport, B. 

Presented by: Eva Larsen, Precision Neuroscience

Objective: We hypothesize that a conformable, high-density thin-film micro-electrode array (the Layer 7 device) can capture neural correlates of speech and movement without penetrating the brain. This approach will enable early clinical testing, accelerating access to brain-computer interface (BCI) technology for individuals living with amyotrophic lateral sclerosis (ALS). 

Methods: The platform uses a surgically reversible thin-film array with 1,024 high-density micro-electrodes (400 µm spacing). Neural data was collected first during intraoperative neural monitoring studies, then extraoperatively with the device left in place for multiple days in patients already undergoing routine neurosurgical procedures. Tasks spanned motor, speech, auditory, and peripheral stimulation mapping paradigms. In the primary motor paradigm, participants controlled a cursor via joystick across a grid; after only 20 minutes of training, our model decoded neural signals without joystick ground truth. 

Results: The Layer 7 BCI device enabled robust multi-modal neural decoding, including high qualitysignal acquisition during voluntary movement. The platform has been tested in 68 patients intraoperatively and implanted for short durations (3 days +/- 2.5) in the hospital setting in 18 patients. The system supported speech decoding and high-spatial-resolution motor mapping, and surgical reversibility was achieved across all implantations. 

Conclusion: These preliminary findings demonstrate that our Layer 7 device shows strong translational potential for next-generation BCI applications. Findings from our patients, clinical partners, and research team are informing the development of a fully implantable BCI system, with the aim to begin deploying the device in ALS patients for hands-free device control.