RecruitingNot ApplicableNCT06368310

FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

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


Sponsor

University of Manchester

Enrollment

10 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is the first-in-human study of graphene-based electrodes used to map brain activity during surgery for people with a brain tumor (glioma), to determine if this new technology is safe and effective for neurosurgical brain mapping. **You may be eligible if...** - You have a brain tumor consistent with glioma on MRI scans - You are scheduled for brain surgery either while awake or under general anesthesia with intraoperative brain monitoring - You have a Karnofsky performance score greater than 70 (able to carry out normal activity with some effort) - If your tumor involves language areas, English must be your first language **You may NOT be eligible if...** - Your tumor is in the back part of the brain (infratentorial region) - You have conditions that would make brain surgery unsafe - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEINBRAIN Graphene Cortical Interface

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


Locations(1)

Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust

Salford, Greater Manchester, United Kingdom

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NCT06368310


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