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

Trial ID: NCT06368310

Interventional - Phase Unknown - Completed

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

Interventions

• INBRAIN Graphene Cortical Interface

Eligibility

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)

Sponsor

University of Manchester, Northern Care Alliance NHS Foundation Trust, European Commission, Inbrain Neuroelectronics

Source: ClinicalTrials.gov

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