FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

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FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06368310
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Manchester
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David J Coope, PhD FRCS
Principal Investigator Affiliation	Northern Care Alliance NHS Foundation Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Glioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Intervention Arm

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.

Interventions

Device: - INBRAIN Graphene Cortical Interface

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.