Graphene cortical electrodes for brain mapping during tumor surgery

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

This will test whether very thin, flexible graphene electrodes are safe and record good brain signals in people having surgery to remove a glioma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Manchester (Academic / other)
• Locations: 1 site (Salford, Greater Manchester)
• Trial ID: NCT06368310 on ClinicalTrials.gov

What this trial studies

This first-in-human investigation places ultra-thin, flexible graphene-based subdural electrodes on the brain surface during planned tumor resection and uses them alongside the hospital's standard monitoring system. The primary focus is on safety during and immediately after surgery, while secondary measures examine signal quality, stimulation capability, and stability of the device over the operation. If the patient is awake for part of the operation, brief language or naming tasks may be used to explore whether brain signals can be decoded. Participants are followed clinically after surgery to monitor for any device-related problems.

Who should consider this trial

Good fit: Adults with a solitary supratentorial tumor likely to be a glioma who are scheduled for craniotomy with intra-operative electrocorticography or awake mapping, have good functional status (Karnofsky >70/WHO ≤1), and can give informed consent are ideal candidates.

Not a fit: Patients with prior cranial surgery or radiotherapy, contraindications to MRI or gadolinium, expected craniotomies smaller than 5 cm, extracranial malignancy, pregnancy/lactation, or significant renal impairment are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, these graphene electrodes could provide better-fitting, higher-quality brain recordings and stimulation that help surgeons map and preserve critical brain functions during tumor removal.

How similar studies have performed: Conventional metal ECoG electrodes and cortical stimulation have an established clinical track record, but the use of graphene-based cortical interfaces in humans is novel and largely untested.

Eligibility criteria

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)

Where this trial is running

Salford, Greater Manchester

• Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust — Salford, Greater Manchester, United Kingdom (Recruiting)

Study contacts

• Principal investigator: David J Coope, PhD FRCS — Northern Care Alliance NHS Foundation Trust
• Study coordinator: Research Governance, Ethics and Integrity Manager

Conditions Brain Tumor; Glioma; Electrocorticography; Subdural electrode; Graphene