FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

NCT06368310 | Recruiting DMC

• 2 other identifiers: R12480723/WM/0166
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor; Glioma

Keywords

Electrocorticography; Subdural electrode; Graphene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assess the ability of the device to record signals from the brain

  During surgical procedure

• Evaluate the ability of the device to provide functional stimulation of the brain

  During surgical procedure

• Assess stability of sensing and stimulating electrodes

  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

  During surgical procedure

Other Outcomes (5)

• Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory)

  During surgical procedure

• Assess the quality of the recorded baseline brain activity - sensing part B (exploratory)

  During surgical procedure

• Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory)

  During surgical procedure

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Interventions

INBRAIN Graphene Cortical Interface DEVICE

Study device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inbrain Neuroelectronics: collaborator
• University of Manchester: lead
• European Commission: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator

Study Sites (1)

Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 38212522 BACKGROUND

• 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

  RESULT

Related Links

• European Union Graphene Flagship

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• David J Coope, PhD FRCS

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Governance, Ethics and Integrity Manager

CONTACT

+441612752725; medicaldevices@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Consultant in Neurosurgery

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 16, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)