FIH Clinical Investigation of Graphene Electrodes for Brain Mapping (NCT06368310) | Clinical Trial Compass
CompletedNot Applicable
FIH Clinical Investigation of Graphene Electrodes for Brain Mapping
United Kingdom10 participantsStarted 2024-08-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the preliminary safety of the investigational device for its intended use
Timeframe: Through study completion, an average of 3 months