At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- INBRAIN Graphene Cortical Interface (device)
- How long the study runs
- Study runs about 22 months (dates as stated)
- About the drug or intervention
- INBRAIN Graphene Cortical Interface — device: Study device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 10
- Started
- 2024-08-06
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for brain tumor
- • NA - 10 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with brain tumor
Where?
- • Salford - Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
During surgical operations within the brain such as the removal of a tumor, electrodes are commonly used to map specific brain functions or monitor brain activity. These are most commonly flexible plastic devices with embedded metallic contacts that allow electrical activity in the brain to be detected and measured. They may also be used to stimulate precise areas of the brain to either trigger or block a response such as the contraction of a muscle. This allows the surgeon to define which regions of the brain are involved in controlling critical functions such as movement or speech so that these areas can be protected during the operation. There remain limitations with the design and physical characteristics of commercially available electrodes for use during brain operations. These include the limited ability of conventional materials to fold over the complex shape of the brain and the need to use comparatively large metallic contacts to detect the tiny electrical signals. This study will be the first to introduce a new generation of electrodes which have been designed to overcome these limitations. They are extremely thin and flexible allowing them to follow the surface of the brain and to be used in locations within and around the brain for which the standard electrodes are unsuitable. The contact surfaces that detect electrical activity and enable and stimulate the brain have been replaced with graphene which is a novel carbon-based material. The use of graphene allows electrodes to be made that are more sensitive to the tiny electrical signals of the brain. This means that they can be much smaller and closer together providing increased detail in the recording and potentially enabling signals to be detected that would previously have required such long recordings that they could not be used to guide decision making during surgery.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Solitary supratentorial tumor radiologically consistent with glioma (intrinsic primary brain tumor) on standard...
- ✓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 agreement to take part for participating in the study.
Who cannot take part
- ✗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 tumour;
- ✗Pregnant or lactating women;
See the full criteria
Where Is This Study? (1 UK site)
Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
Salford M6 8HD, United Kingdom