INBRAIN Neuroelectronics has announced the interim analysis of findings from the world’s first-in-human clinical study of its graphene-based brain-computer interface (BCI) technology. The study, sponsored by the University of Manchester and conducted at the Manchester Centre for Clinical Neurosciences (Northern Care Alliance NHS Foundation Trust), is evaluating the safety and functional performance of graphene-based electrodes when used during surgery for resection of brain tumors.
The primary objective of the study (NCT06368310) is to assess the safety of INBRAIN’s brain-computer interface (BCI) during brain tumor surgery. Secondary objectives include evaluating the quality of neural signals captured by the device, its ability to deliver targeted brain stimulation, the consistency of its performance throughout the procedure, and its overall suitability for use in the neurosurgical operating room. A total of 8 to 10 patients are expected to be enrolled to validate the safety and functional performance of the graphene-based BCI. The study design included an interim analysis after the first four patients had been recruited to ensure patient safety and data quality.
Interim analysis of the results from the first cohort of four patients enrolled in the study demonstrated no device-related adverse events, a key component of the primary endpoint of the study. During awake language mapping, the device captured distinct high gamma activity linked to different phonemes, the smallest units of sound in speech, showcasing exceptional spatial and temporal resolution, even with micrometer-scale contacts. The ultra-thin, sub-micrometer graphene electrodes also proved compatible with commercially available, CE-marked electrophysiology systems, reliably recording real-time brain signals throughout the surgical procedures.
“The ability to detect high-frequency neural activity with micrometer-scale precision opens new possibilities for understanding brain-tumor interactions and broader brain function in neuro-related disorders,” said Mr. David Coope, Chief Investigator and Consultant Neurosurgeon at the Manchester Centre for Clinical Neurosciences, the Geoffrey Jefferson Brain Research Centre and the University of Manchester. “This technology could be transformative, not only for improving surgical outcomes but for unlocking new treatment pathways.”
Throughout the procedures, INBRAIN’s BCI enabled high-resolution brain signal monitoring, addressing one of the most pressing challenges in neurosurgery: achieving precise tumor removal while preserving essential functions such as speech, movement, and cognition. The device was used in parallel with standard clinical monitoring tools, maintaining consistent performance across the surgical window.
“This milestone demonstrates that graphene-based brain-computer interfaces can be deployed in the operating room and deliver a level of neural fidelity not achievable with traditional materials,” said Carolina Aguilar, CEO and Co-Founder, INBRAIN Neuroelectronics. “We’re moving toward a future where neurosurgeons and neurologists can rely on real-time, high-definition brain data to guide personalized interventions.”
INBRAIN’s platform is powered by ultra-flexible, thin-film graphene semiconductors that conform more precisely to the brain surface than conventional strip electrodes. The BCI features high-density, multiscale, bidirectional contacts for superior decoding and modulation, and reduced graphene oxide (rGO) nanoporous matrices that enhance sensitivity and signal resolution. In preclinical studies, the GCI significantly outperformed platinum-based electrodes in detecting high gamma frequencies (80–130 Hz) critical for speech decoding, with statistical significance (p < 0.01).
Graphene technology offers several benefits for neurosurgical procedures. It enhances surgical precision by enabling smaller and more densely packed electrodes, allowing surgeons to define and preserve critical functional areas during tumor resection. Its flexibility enables accurate decoding and mapping in anatomically complex or hard-to-access brain regions, including the walls of the tumor resection cavity. Additionally, the device’s ability to decode high-frequency activity offers huge scientific opportunities including the potential to reveal in situ interactions between glioma cells and neurons, offering potential insights into new therapeutic targets for halting tumor progression.
“We’re not delivering incremental innovation, we’re enabling entirely new capabilities,” said Kostas Kostarelos, Co-Founder of INBRAIN and Chief Scientific Investigator of the study and Professor of Nanomedicine at the University of Manchester, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) in Barcelona, and Programme Lead for the Next Generation Therapeutics Theme of the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC). “This convergence of advanced materials science, neuroscience, and AI is shaping the future of real-time, precision neurology.”
As the first safety study of a graphene-based neural interface in humans, this study marks a foundational step toward the development of BCI therapeutic systems for chronic neurological diseases, pioneering a new era of real-time, precision neurology.
