Clinical trial NCT06368310: FIH Clinical Investigation of Graphene Electrodes for Brain Mapping
Official title: First in Human (FIH) Clinical Investigation of Safety and Feasibility of a Novel Graphene Micro-electrocorticography Array for Brain Mapping in Neuro-oncology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Tumor
Glioma
Keywords: Electrocorticography
Subdural electrode
Graphene
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Northern Care Alliance NHS Foundation Trust
name: European Commission
name: Inbrain Neuroelectronics
First posted: 2024-04-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

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)

Primary outcomes:
measure: To evaluate the preliminary safety of the investigational device for its intended use
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Assess the ability of the device to record signals from the brain
timeFrame: During surgical procedure
measure: Evaluate the ability of the device to provide functional stimulation of the brain
timeFrame: During surgical procedure
measure: Assess stability of sensing and stimulating electrodes
timeFrame: During surgical procedure
measure: 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
timeFrame: During surgical procedure
Other outcomes:
measure: Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory)
timeFrame: During surgical procedure
measure: Assess the quality of the recorded baseline brain activity - sensing part B (exploratory)
timeFrame: During surgical procedure
measure: Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory)
timeFrame: During surgical procedure
measure: Evaluate decoding capability from data recorded during language task (exploratory)
timeFrame: During surgical procedure
measure: Evaluate signal characteristics of tumour infiltrated brain regions (exploratory)
timeFrame: During surgical procedure
Locations:
city: Salford
country: United Kingdom
facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: Northern Care Alliance NHS Foundation Trust
name: David J Coope, PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.