A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma

A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma

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.

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.

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