Graphene Micro-electrode Array for Brain Mapping in Neuro-oncology
The study aims to evaluate the preliminary safety of a graphene micro-electrode array used for brain mapping in patients with brain tumors by monitoring any adverse events.
INBRAIN Graphene Cortical Interface
Brain Diseases+12
+ Brain Neoplasms
+ Central Nervous System Diseases
Device Feasibility Study
Summary
Study start date: July 22, 2024
Actual date on which the first participant was enrolled.This study focuses on testing a new type of electrode used during brain surgeries, especially those involving the removal of tumors. Traditional electrodes are made of plastic with metal contacts and help map brain functions to protect important areas during surgery. However, these electrodes have design limitations, as they struggle to conform to the brain's complex shape and require large contacts to detect electrical signals. This study aims to introduce electrodes made with graphene, a new, thinner, and more flexible material that can detect smaller signals more accurately. This advancement could help surgeons identify critical brain areas with greater precision, potentially improving surgical outcomes and patient safety. Participants undergoing brain surgery, such as tumor removal, will have these new graphene electrodes used during their procedure. The electrodes will be placed on the brain's surface to monitor electrical activity and help pinpoint areas controlling essential functions like movement or speech. The study will observe how well these electrodes conform to the brain's shape and their ability to provide detailed and accurate readings. While the potential benefits include improved mapping accuracy and better protection of vital brain areas, the study will also monitor any possible risks associated with using this novel material in a surgical setting.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
Salford, United KingdomOpen Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust in Google Maps