FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

Glioma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368310
• Other study ID #: R124807
• Secondary ID: 23/WM/0166
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 28, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: University of Manchester
• Contact: Research Governance, Ethics and Integrity Manager
• Phone: +441612752725
• Email: medicaldevices[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 these new electrodes when used during brain tumor surgery (primary objective);

• To assess the quality of the brain signals recorded with the new electrodes, 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. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioma

Intervention

Device:
• INBRAIN Graphene Cortical Interface
Study device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring.

Locations

Country	Name	City	State
United Kingdom	Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust	Salford	Greater Manchester

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	Assess stability of sensing and stimulating electrodes	Stability of electrodes by evaluation of impedance measurements over time	During surgical procedure
Secondary	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	During surgical procedure

External Links

•   European Union Graphene Flagship