Brain TumorNCT06368310
FIH Clinical Investigation of Graphene Electrodes for Brain Mapping
A study testing INBRAIN Graphene Cortical Interface in people with Brain Tumor and Glioma, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Glioma
- What is being tested?
- INBRAIN Graphene Cortical Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2024to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
About this study
Official title: First in Human (FIH) Clinical Investigation of Safety and Feasibility of a Novel Graphene Micro-electrocorticography Array for Brain Mapping in Neuro-oncology
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.
Read the detailed description
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.
- Conditions
- Brain Tumor, Glioma
- Being tested
- INBRAIN Graphene Cortical Interface
- Keywords
- Electrocorticography, Subdural electrode, Graphene
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INBRAIN Graphene Cortical InterfaceDevice
Study device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients with suspected gliomas (intrinsic primary brain tumors) in whom surgical resection under general anesthesia with neurophysiological monitoring or under awake conditions where language mapping is planned. Receives: Device: INBRAIN Graphene Cortical Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the preliminary safety of the investigational device for its intended use
All adverse events (including, but not limited to, adverse device events)
Measured: Through study completion, an average of 3 months
Secondary outcomes (4)
Assess the ability of the device to record signals from the brain
Performance of detecting signals from the brain by sensing of electrical brain activity
Measured: During surgical procedure
Evaluate the ability of the device to provide functional stimulation of the brain
Performance of functional stimulation of the brain by inducing evoked motor responses measured as peripheral muscle electromyography (EMG)
Measured: During surgical procedure
Assess stability of sensing and stimulating electrodes
Stability of electrodes by evaluation of impedance measurements over time
Measured: During surgical procedure
Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery
Study specific questionnaire to be completed by the operating surgeon including ease of handling, positioning and removal of the electrode. The study specific 'Device Usability' tool scores outcomes on a scale of 1-4 where 4 represents a favourable feature.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start6 Aug 2024
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust, European Commission, Inbrain Neuroelectronics
- Responsible party
- Principal investigator, David Coope, Northern Care Alliance NHS Foundation Trust
- Investigators
- David J Coope, PhD FRCS, Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368310
- Sponsor's protocol ID
- R124807
- Other IDs
- 23/WM/0166
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Viana D, Walston ST, Masvidal-Codina E, Illa X, Rodriguez-Meana B, Del Valle J, Hayward A, Dodd A, Loret T, Prats-Alfonso E, de la Oliva N, Palma M, Del Corro E, Del Pilar Bernicola M, Rodriguez-Lucas E, Gener T, de la Cruz JM, Torres-Miranda M, Duvan FT, Ria N, Sperling J, Marti-Sanchez S, Spadaro MC, Hebert C, Savage S, Arbiol J, Guimera-Brunet A, Puig MV, Yvert B, Navarro X, Kostarelos K, Garrido JA. Nanoporous graphene-based thin-film microelectrodes for in vivo high-resolution neural recording and stimulation. Nat Nanotechnol. 2024 Apr;19(4):514-523. doi: 10.1038/s41565-023-01570-5. Epub 2024 Jan 11.
PubMed 38212522Coope DJ, Lodwick S, Bambrough J, Karabatsou K, Maye H, Nambiar R, Donega M, Ruiz Sanchez-Beato M, Perez Vazquez A, Saiz-Alia M, Ortega P, Maull A, de la Cruz JM, Viana D, Garrido J, Kostarelos K. SURG-92: FIRST-IN-HUMAN STUDY OF A GRAPHENE CORTICAL INTERFACE FOR HIGH-PRECISION, HIGH-FIDELITY BRAIN-TO-TUMOR MAPPING REVEALS HIGH GAMMA ACTIVITY CAPABILITY: INTERIM ANALYSIS. Neuro-Oncology, Volume 27, Issue Supplement_5, November 2025, Page v415, https://doi.org/10.1093/neuonc/noaf201.1644
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human (FIH) Clinical Investigation of Safety and Feasibility of a Novel Graphene Micro-electrocorticography Array for Brain Mapping in Neuro-oncology
- ClinicalTrials.gov ID
- NCT06368310
- Acronym / sponsor ID
- R124807
- Conditions
- Brain Tumor, Glioma
- Keywords
- Electrocorticography, Subdural electrode, Graphene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust, European Commission, Inbrain Neuroelectronics
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: INBRAIN Graphene Cortical InterfacePatients with suspected gliomas (intrinsic primary brain tumors) in whom surgical resection under general anesthesia with neurophysiological monitoring or under awake conditions where language mapping is planned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INBRAIN Graphene Cortical InterfaceStudy device to be evaluated intra-operatively alongside standard of care neurophysiological monitoring. | Device | Intervention Arm |
Primary outcome
To evaluate the preliminary safety of the investigational device for its intended use
Time frame: Through study completion, an average of 3 months
All adverse events (including, but not limited to, adverse device events)
4 secondary outcomes
Assess the ability of the device to record signals from the brain
Time frame: During surgical procedure
Evaluate the ability of the device to provide functional stimulation of the brain
Time frame: During surgical procedure
Assess stability of sensing and stimulating electrodes
Time frame: During surgical procedure
Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery
Time frame: During surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 38212522Viana D, Walston ST, Masvidal-Codina E, Illa X, Rodriguez-Meana B, Del Valle J, Hayward A, Dodd A, Loret T, Prats-Alfonso E, de la Oliva N, Palma M, Del Corro E, Del Pilar Bernicola M, Rodriguez-Lucas E, Gener T, de la Cruz JM, Torres-Miranda M, Duvan FT, Ria N, Sperling J, Marti-Sanchez S, Spadaro MC, Hebert C, Savage S, Arbiol J, Guimera-Brunet A, Puig MV, Yvert B, Navarro X, Kostarelos K, Garrido JA. Nanoporous graphene-based thin-film microelectrodes for in vivo high-resolution neural recording and stimulation. Nat Nanotechnol. 2024 Apr;19(4):514-523. doi: 10.1038/s41565-023-01570-5. Epub 2024 Jan 11.
- Results publicationCoope DJ, Lodwick S, Bambrough J, Karabatsou K, Maye H, Nambiar R, Donega M, Ruiz Sanchez-Beato M, Perez Vazquez A, Saiz-Alia M, Ortega P, Maull A, de la Cruz JM, Viana D, Garrido J, Kostarelos K. SURG-92: FIRST-IN-HUMAN STUDY OF A GRAPHENE CORTICAL INTERFACE FOR HIGH-PRECISION, HIGH-FIDELITY BRAIN-TO-TUMOR MAPPING REVEALS HIGH GAMMA ACTIVITY CAPABILITY: INTERIM ANALYSIS. Neuro-Oncology, Volume 27, Issue Supplement_5, November 2025, Page v415, https://doi.org/10.1093/neuonc/noaf201.1644
- European Union Graphene FlagshipLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Coope, PhD FRCS principal investigator
Northern Care Alliance NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INBRAIN Graphene Cortical Interface in people with Brain Tumor and Glioma, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the preliminary safety of the investigational device for its intended use (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.