GliomaCIPHERNCT07465796
A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
A study testing Electrocorticography for neural recording and Electrocorticography for neural recording and electrical stimulation in people with Glioma and Tumor, run by Coherence Neuro Australia Pty Limited at 1 site in Australia.
Trial summary
The goal of this clinical trial is to collect data on the use of the CIPHER System when used by a surgeon during brain tumor removal. The main questions it aims to answer are: To evaluate the safety of the CIPHER System when used during brain tumor surgery (Primary) To evaluate the function of the electrodes under… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma, Tumor, Electrocorticography
- What is being tested?
- Electrocorticography for neural recording and Electrocorticography for neural recording and electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 22 May 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed supratentorial glioma requiring resection
- Glioma mass reaches or close to cortical surface
- Adults aged 18-75
- Planned for open craniotomy under Total Intravenous Anesthesia (TIVA)
- Patient able to provide informed consent
- Performance status: Eastern Cooperative Oncology Group (ECOG) scale 0-2
Who cannot join
- Prior craniotomy at the same anatomical location
- Plan for awake craniotomy
- Any history of seizures prior to craniotomy
- Any history of coagulopathy or coagulation disorders
- Pregnant status during craniotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Royal Melbourne Hospital, Department of Neurosurgery 4 East
Melbourne, Victoria, 3050
Andrew Morokoff, MBBS PhD FRACS, +61 393 482 712, morokoff@unimelb.edu.au
Andrew Morokoff, MBBS PhD FRACS
About this study
The goal of this clinical trial is to collect data on the use of the CIPHER System when used by a surgeon during brain tumor removal. The main questions it aims to answer are:
- To evaluate the safety of the CIPHER System when used during brain tumor surgery (Primary)
- To evaluate the function of the electrodes under recording and stimulating conditions during surgery (Secondary) Participants will undergo standard-of-care surgery to remove their tumor. Just before the tumor is removed, the CIPHER System will be tested on the main tumor and the surrounding margin areas. Participants will be monitored during standard hospital visits occurring during the recovery period after surgery as well as two- and six-weeks after surgery.
Read the detailed description
Brain tumor resection surgery involves a balance between removing tumor and preserving healthy tissue. Current standard-of-care mapping tools use limited electrode configurations on rigid substrates to stimulate and record brain activity for identifying functional brain areas to avoid. A more flexible and high electrode-count tool to map the tumor characteristics based on spontaneous neural activity could strengthen surgical outcomes.
Emerging evidence also demonstrates that brain tumors, such as gliomas, are not biologically isolated but instead integrate functionally into neural circuits. Electrical stimulation-based strategies could provide novel treatment modalities that target the neural-tumour interactions and improve patient outcomes.
This clinical investigation is a First-in-Human exploratory study of the CIPHER System, including a novel highly flexible, electrode-dense thin-film cortical probe developed for neurophysiological mapping and stimulation during brain tumour resection surgery. The study is designed to evaluate the safety, basic performance, and handling characteristics of the CIPHER System during short-duration intraoperative use.
- Conditions
- Glioma, Tumor, Electrocorticography, Brain
- Being tested
- Electrocorticography for neural recording, Electrocorticography for neural recording and electrical stimulation
- Keywords
- Intraoperative Neurophysiology, Cortical Mapping, Cortical Stimulation, Brain-Computer Interface (BCI)
- Medical subject headings
- Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocorticography for neural recordingDevice
Electrocorticography probe placed on the brain surface for neural recording
Electrocorticography for neural recording and electrical stimulationDevice
Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Recording only | Experimental | Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered. Receives: Device: Electrocorticography for neural recording |
| Recording and Stimulation | Experimental | Participants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered Receives: Device: Electrocorticography for neural recording and electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device
Monitoring of all device/procedure-related adverse events including, but not limited to, device-related postoperative observations for persistent seizures or status epilepticus
Measured: From enrollment to the end of postoperative six-week follow-up visit
Secondary outcomes (4)
Presence or absence of spontaneous neural activity on recording electrodes
Presence or absence of spontaneous cortical signals on each electrode within the array
Measured: At enrollment
Signal-to-noise ratio of recorded signals
Signal-to-noise ratio of recorded signals on each recording electrode
Measured: At enrollment
Evaluate local field potential neural activity before and after stimulation
Preliminary comparison of neural power spectra of local field potentials before and after stimulation
Measured: At enrollment
Incidence and characterization of device deficiencies during intraoperative use
Evaluation of the operating surgeon's responses to a study specific questionnaire including free text description of deficiency, categorization of the type of deficiency as well as outcomes and potential outcomes of deficiencies.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start22 May 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coherence Neuro Australia Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Melbourne Hospital, Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465796
- Sponsor's protocol ID
- CL_CNS_00008
- Other IDs
- HREC 474/25
- Acronym
- CIPHER
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared in order to preserve patient confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma
- ClinicalTrials.gov ID
- NCT07465796
- Acronym / sponsor ID
- CIPHER / CL_CNS_00008
- Conditions
- Glioma, Tumor, Electrocorticography, Brain
- Keywords
- Intraoperative Neurophysiology, Cortical Mapping, Cortical Stimulation, Brain-Computer Interface (BCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Coherence Neuro Australia Pty LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Royal Melbourne Hospital, Australia
- Study start
- 22 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Mar 2026 (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 trial is to collect data on the use of the CIPHER System when used by a surgeon during brain tumor removal. The main questions it aims to answer are:
- To evaluate the safety of the CIPHER System when used during brain tumor surgery (Primary)
- To evaluate the function of the electrodes under recording and stimulating conditions during surgery (Secondary) Participants will undergo standard-of-care surgery to remove their tumor. Just before the tumor is removed, the CIPHER System will be tested on the main tumor and the surrounding margin areas. Participants will be monitored during standard hospital visits occurring during the recovery period after surgery as well as two- and six-weeks after surgery.
Detailed description
Brain tumor resection surgery involves a balance between removing tumor and preserving healthy tissue. Current standard-of-care mapping tools use limited electrode configurations on rigid substrates to stimulate and record brain activity for identifying functional brain areas to avoid. A more flexible and high electrode-count tool to map the tumor characteristics based on spontaneous neural activity could strengthen surgical outcomes.
Emerging evidence also demonstrates that brain tumors, such as gliomas, are not biologically isolated but instead integrate functionally into neural circuits. Electrical stimulation-based strategies could provide novel treatment modalities that target the neural-tumour interactions and improve patient outcomes.
This clinical investigation is a First-in-Human exploratory study of the CIPHER System, including a novel highly flexible, electrode-dense thin-film cortical probe developed for neurophysiological mapping and stimulation during brain tumour resection surgery. The study is designed to evaluate the safety, basic performance, and handling characteristics of the CIPHER System during short-duration intraoperative use.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recording only | Experimental | Device: Electrocorticography for neural recordingParticipants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded. No stimulation will be delivered. |
| Recording and Stimulation | Experimental | Device: Electrocorticography for neural recording and electrical stimulationParticipants will have the CIPHER Probe placed on the brain surface and neural activity will be recorded and stimulation will be delivered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed supratentorial glioma requiring resection
- Glioma mass reaches or close to cortical surface
- Adults aged 18-75
- Planned for open craniotomy under Total Intravenous Anesthesia (TIVA)
- Patient able to provide informed consent
Key exclusion criteria (5 listed)
- Prior craniotomy at the same anatomical location
- Plan for awake craniotomy
- Any history of seizures prior to craniotomy
- Any history of coagulopathy or coagulation disorders
- Pregnant status during craniotomy
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 |
|---|---|---|
| Electrocorticography for neural recordingElectrocorticography probe placed on the brain surface for neural recording | Device | Recording only |
| Electrocorticography for neural recording and electrical stimulationElectrocorticography probe placed on the brain surface for neural recording and electrical stimulation | Device | Recording and Stimulation |
Primary outcome
Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device
Time frame: From enrollment to the end of postoperative six-week follow-up visit
Monitoring of all device/procedure-related adverse events including, but not limited to, device-related postoperative observations for persistent seizures or status epilepticus
4 secondary outcomes
Presence or absence of spontaneous neural activity on recording electrodes
Time frame: At enrollment
Signal-to-noise ratio of recorded signals
Time frame: At enrollment
Evaluate local field potential neural activity before and after stimulation
Time frame: At enrollment
Incidence and characterization of device deficiencies during intraoperative use
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared in order to preserve patient confidentiality
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocorticography for neural recording and Electrocorticography for neural recording and electrical stimulation in people with Glioma and Tumor, run by Coherence Neuro Australia Pty Limited at 1 site in Australia.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Morokoff, MBBS PhD FRACS (+61 393 482 712, morokoff@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device (time frame: From enrollment to the end of postoperative six-week follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.