FIH Clinical Investigation of Graphene Electrodes for Brain Mapping
NCT: NCT06368310 · RECRUITING
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.
Frequently Asked Questions
What is FIH Clinical Investigation of Graphene Electrodes for Brain Mapping?
FIH Clinical Investigation of Graphene Electrodes for Brain Mapping is a clinical trial registered under NCT06368310. Current status: RECRUITING.
What is the status of NCT06368310?
The current status of NCT06368310 (FIH Clinical Investigation of Graphene Electrodes for Brain Mapping) is: RECRUITING.
When did FIH Clinical Investigation of Graphene Electrodes for Brain Mapping start?
FIH Clinical Investigation of Graphene Electrodes for Brain Mapping started on 2024-08-06.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.