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| ID | Type | Description | Link |
|---|---|---|---|
| HREC 474/25 | Other Identifier | St Vincent's Hospital Melbourne |
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| Name | Class |
|---|---|
| Royal Melbourne Hospital, Australia | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocorticography for neural recording | Device | Electrocorticography probe placed on the brain surface for neural recording |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of postoperative six-week follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of spontaneous neural activity on recording electrodes | Presence or absence of spontaneous cortical signals on each electrode within the array | At enrollment |
| Signal-to-noise ratio of recorded signals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Morokoff, MBBS PhD FRACS | Contact | +61 393 482 712 | morokoff@unimelb.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Melbourne Hospital, Department of Neurosurgery 4 East | Recruiting | Melbourne | Victoria | 3050 | Australia |
IPD will not be shared in order to preserve patient confidentiality
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| Electrocorticography for neural recording and electrical stimulation | Device | Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation |
|
Signal-to-noise ratio of recorded signals on each recording electrode
| 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 | 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. | At enrollment |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000069280 | Electrocorticography |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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