- Graphene-based BCI demonstrates high-resolution brain decoding and mapping in patients undergoing tumor resection at the Manchester Centre for Clinical Neurosciences
- Initial four patient cohort has shown no safety concerns to date that would prevent the completion of this first-in-human study.
INBRAIN Neuroelectronics today 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.
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Image caption: INBRAIN BCI Cortical Film; Image credit: INBRAIN Neuroelectronics
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).
Clinical Advantages
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.
About INBRAIN Neuroelectronics
INBRAIN Neuroelectronics is pioneering real-time precision neurology with the world's first graphene-based brain-computer interface (BCI) therapeutics platform. Our technology combines precise BCI decoding with micrometric modulation to deliver adaptive, personalized treatments for conditions such as Parkinson's disease, epilepsy, and stroke rehabilitation. By providing continuous real-time monitoring and autonomous therapy adjustments, our AI-driven platform maximizes therapeutic outcomes while minimizing side effects. Through strategic collaborations, including with Merck KGAa and our subsidiary INNERVIA Bioelectronics, we are extending our innovative solutions to peripheral nerve and systemic disease applications, unlocking the potential of neurotechnology and bioelectronics. For more information, visit www.inbrain-neuroelectronics.com and follow us on LinkedIn.
About Northern Care Alliance (NCA)
Northern Care Alliance NHS Foundation Trust provides hospital and community healthcare services in Salford, Oldham, Bury and Rochdale. Our dedicated team of around 20,000 staff delivers high standards of care and experience excellence to over one million people across Greater Manchester and beyond, working together to save lives and improve lives. More information about the NCA can be found at www.northerncarealliance.nhs.uk
About the National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK international development funding from the UK government.
About the NIHR Manchester Biomedical Research Centre (BRC)
The NIHR Manchester Biomedical Research Centre (BRC) transforms scientific breakthroughs into diagnostic tests and life-saving treatments for patients. NIHR Biomedical Research Centres (BRCs) are collaborations between NHS organisations and universities. They bring together academics and clinicians to translate scientific discoveries into potential new treatments, diagnostics and technologies. Manchester BRC is hosted by Manchester University NHS Foundation Trust and The University of Manchester in partnership with five NHS trusts; Blackpool Teaching Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, and the Northern Care Alliance NHS Foundation Trust.
About The University of Manchester
The University of Manchester is recognised globally for its pioneering research, outstanding teaching and learning, and commitment to social responsibility. The Russell Group institution is ranked the 6th best university in the UK and 38th in the world (Academic Ranking of World Universities). A truly international university, its community includes more than 44,000 students, 12,000 staff, and 500,000 alumni from 190 countries. Together, they are tackling the world's biggest challenges the University's social and environmental impact is ranked in the top ten globally (Times Higher Education Impact Rankings). The University is a powerhouse of research and discovery; 25 Nobel laureates are among its former staff and students; and it was ranked fifth for research power the quality and scale of research and impact in the UK government's Research Excellence Framework (REF) 2021. The institution is the most popular in the UK for undergraduate applications (UCAS 2021 cycle), and it is the it is the most targeted university by the UK's leading employers (The Graduate Market, 2023).
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