Brain, Electrocorticography, Glioma, Tumor
Conditions
Keywords
Intraoperative Neurophysiology, Cortical Mapping, Cortical Stimulation, Brain-Computer Interface (BCI)
Brief 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 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.
Interventions
DEVICEElectrocorticography for neural recording
Electrocorticography probe placed on the brain surface for neural recording
DEVICEElectrocorticography for neural recording and electrical stimulation
Electrocorticography probe placed on the brain surface for neural recording and electrical stimulation
Sponsors
Coherence Neuro Australia Pty Limited
Royal Melbourne Hospital, Australia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all device/procedure-related adverse events (safety and tolerability) relevant to the intended use of the study device | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of spontaneous neural activity on recording electrodes | At enrollment | Presence or absence of spontaneous cortical signals on each electrode within the array |
| Signal-to-noise ratio of recorded signals | At enrollment | Signal-to-noise ratio of recorded signals on each recording electrode |
| Evaluate local field potential neural activity before and after stimulation | At enrollment | Preliminary comparison of neural power spectra of local field potentials before and after stimulation |
| Incidence and characterization of device deficiencies during intraoperative use | At enrollment | 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. |
Countries
Australia
Contacts
CONTACTAndrew Morokoff, MBBS PhD FRACS
Outcome results
None listed