Actively Recruiting
FIH Clinical Investigation of Graphene Electrodes for Brain Mapping
Led by University of Manchester · Updated on 2026-03-25
10
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
U
University of Manchester
Lead Sponsor
N
Northern Care Alliance NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FIH Clinical Investigation of Graphene Electrodes for Brain Mapping
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Solitary supratentorial tumor consistent with glioma on MRI
- Scheduled for surgery either awake or under general anesthesia with intra-operative electrocorticography
- English as first language for subjects with tumors near language areas
- Karnofsky performance score above 70 and WHO performance status score 1 or less
- Able and willing to provide informed consent
You will not qualify if you...
- Contraindications to MRI such as incompatible implanted devices
- Previous brain surgery or radiotherapy
- Expected craniotomy smaller than 5 cm in diameter
- Known cancer outside the brain
- Pregnant or breastfeeding women
- Renal impairment limiting contrast agent use (EGFR less than 60 ml/min)
- Contraindications preventing awake intra-operative language tasks for relevant tumors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, United Kingdom, M6 8HD
Actively Recruiting
Research Team
R
Research Governance, Ethics and Integrity Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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