FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

First in Human (FIH) Clinical Investigation of Safety and Feasibility of a Novel Graphene Micro-electrocorticography Array for Brain Mapping in Neuro-oncology

The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:

• To understand the safety of the Graphene Cortical Interface when used during brain tumor surgery (primary objective);
• To assess the quality of the brain signals recorded with the Graphene Cortical Interface, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).

Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study, to evaluate the capability to decode brain signals (exploratory objective). They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Brain Tumor
• Intervention / Treatment: Device: INBRAIN Graphene Cortical Interface

Detailed Description

During surgical operations within the brain such as the removal of a tumor, electrodes are commonly used to map specific brain functions or monitor brain activity. These are most commonly flexible plastic devices with embedded metallic contacts that allow electrical activity in the brain to be detected and measured. They may also be used to stimulate precise areas of the brain to either trigger or block a response such as the contraction of a muscle. This allows the surgeon to define which regions of the brain are involved in controlling critical functions such as movement or speech so that these areas can be protected during the operation.

There remain limitations with the design and physical characteristics of commercially available electrodes for use during brain operations. These include the limited ability of conventional materials to fold over the complex shape of the brain and the need to use comparatively large metallic contacts to detect the tiny electrical signals. This study will be the first to introduce a new generation of electrodes which have been designed to overcome these limitations. They are extremely thin and flexible allowing them to follow the surface of the brain and to be used in locations within and around the brain for which the standard electrodes are unsuitable. The contact surfaces that detect electrical activity and enable and stimulate the brain have been replaced with graphene which is a novel carbon-based material. The use of graphene allows electrodes to be made that are more sensitive to the tiny electrical signals of the brain. This means that they can be much smaller and closer together providing increased detail in the recording and potentially enabling signals to be detected that would previously have required such long recordings that they could not be used to guide decision making during surgery.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Governance, Ethics and Integrity Manager; Phone Number: +441612752725; Email: medicaldevices@manchester.ac.uk

Study Locations

• United Kingdom
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Recruiting
      • Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
      • Contact: Hannah Howlett; Email: RDResearch@nca.nhs.uk
      • Principal Investigator: David J Coope, PhD FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Solitary supratentorial tumor radiologically consistent with glioma (intrinsic primary brain tumor) on standard diagnostic MRI;
• Planned for surgery under awake conditions or under general anesthesia with intra-operative electrocorticography (ECoG);
• English as first language for those subjects with tumors associated with language areas;
• Karnofsky performance score > 70 and World Health Organization (WHO) performance status score ≤ 1;
• Willing and able to understand and provide informed consent for participating in the study.

Exclusion Criteria:

• Contraindications to magnetic resonance imaging (e.g., incompatible implanted devices);
• Previous cranial surgery or radiotherapy;
• Subjects expected to undergo craniotomy of less than 5 cm in maximum diameter (bone to bone)
• Known extracranial malignant neoplasm;
• Pregnant or lactating women;
• Renal impairment sufficient to limit Gadolinium administration (EGFR <60 ml/min)
• For those subjects with tumors associated with language areas, any contraindication which could preclude them from performing the whole awake intra operative tasks at the discretion of the Investigator (e.g., language function not suitable for monitoring tasks)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Patients with suspected gliomas (intrinsic primary brain tumors) in whom surgical resection under general anesthesia with neurophysiological monitoring or under awake conditions where language mapping is planned.	Device: INBRAIN Graphene Cortical Interface; Study device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the preliminary safety of the investigational device for its intended use	All adverse events (including, but not limited to, adverse device events)	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the ability of the device to record signals from the brain	Performance of detecting signals from the brain by sensing of electrical brain activity	During surgical procedure
Evaluate the ability of the device to provide functional stimulation of the brain	Performance of functional stimulation of the brain by inducing evoked motor responses measured as peripheral muscle electromyography (EMG)	During surgical procedure
Assess stability of sensing and stimulating electrodes	Stability of electrodes by evaluation of impedance measurements over time	During surgical procedure
Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery	Study specific questionnaire to be completed by the operating surgeon including ease of handling, positioning and removal of the electrode. The study specific 'Device Usability' tool scores outcomes on a scale of 1-4 where 4 represents a favourable feature.	During surgical procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory)	Assessing the quality of recorded brain activity by measuring signal to noise ratio (SNR) during stimulation of a peripheral nerve	During surgical procedure
Assess the quality of the recorded baseline brain activity - sensing part B (exploratory)	Assessing the quality of recorded brain activity at rest (or under anaesthesia) evaluated as the power spectral density (PSD)	During surgical procedure
Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory)	Preliminary assessment of the ability of the device to detect changes in brain activity evoked in response to stimulation of distant but connected brain regions	During surgical procedure
Evaluate decoding capability from data recorded during language task (exploratory)	Preliminary evaluation of the ability to detect changes in brain activity that correspond to word or sound generation as the participant completes a standardized object naming task (quantified by classification accuracy)	During surgical procedure
Evaluate signal characteristics of tumour infiltrated brain regions (exploratory)	Preliminary evaluation of changes in the pattern of brain activity in healthy brain versus that infiltrated by tumour quantified by changes in the power spectral density (PSD)	During surgical procedure

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Northern Care Alliance NHS Foundation Trust; European Commission; Inbrain Neuroelectronics
• Investigators: Principal Investigator: David J Coope, PhD FRCS, Northern Care Alliance NHS Foundation Trust

Publications and helpful links

General Publications

• Viana D, Walston ST, Masvidal-Codina E, Illa X, Rodriguez-Meana B, Del Valle J, Hayward A, Dodd A, Loret T, Prats-Alfonso E, de la Oliva N, Palma M, Del Corro E, Del Pilar Bernicola M, Rodriguez-Lucas E, Gener T, de la Cruz JM, Torres-Miranda M, Duvan FT, Ria N, Sperling J, Marti-Sanchez S, Spadaro MC, Hebert C, Savage S, Arbiol J, Guimera-Brunet A, Puig MV, Yvert B, Navarro X, Kostarelos K, Garrido JA. Nanoporous graphene-based thin-film microelectrodes for in vivo high-resolution neural recording and stimulation. Nat Nanotechnol. 2024 Apr;19(4):514-523. doi: 10.1038/s41565-023-01570-5. Epub 2024 Jan 11.
• Coope DJ, Lodwick S, Bambrough J, Karabatsou K, Maye H, Nambiar R, Donega M, Ruiz Sanchez-Beato M, Perez Vazquez A, Saiz-Alia M, Ortega P, Maull A, de la Cruz JM, Viana D, Garrido J, Kostarelos K. SURG-92: FIRST-IN-HUMAN STUDY OF A GRAPHENE CORTICAL INTERFACE FOR HIGH-PRECISION, HIGH-FIDELITY BRAIN-TO-TUMOR MAPPING REVEALS HIGH GAMMA ACTIVITY CAPABILITY: INTERIM ANALYSIS. Neuro-Oncology, Volume 27, Issue Supplement_5, November 2025, Page v415, https://doi.org/10.1093/neuonc/noaf201.1644

Helpful Links

• European Union Graphene Flagship

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Electrocorticography; Subdural electrode; Graphene
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Central Nervous System Neoplasms; Glioma; Brain Neoplasms
• Other Study ID Numbers: R124807; 23/WM/0166 (Other Identifier: NHS Research Ethics Committee Reference)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No