Intraoperative Neurophysiological Monitoring
Conditions
Keywords
cortical electrode, IONM
Brief summary
This clinical investigation is a pilot, first-in-human (FIH) study designed to demonstrate proof of concept, safety, and functional performance of the MINDZ subdural electrode grid when used in relevant neurosurgical settings. The study will provide initial clinical evidence to support future conformity assessment and CE marking under the European Medical Device Regulation (MDR). The investigational device, MINDZ, developed by Neurosoft Bioelectronics, is a novel, soft and highly conformable subdural electrode grid designed for minimally invasive implantation through a burr hole. Its flexible structure is intended to improve conformity to the cortical surface, reduce dead space between the electrode and brain tissue, and potentially lower the risk of complications associated with craniotomy, while maintaining adequate cortical coverage for effective monitoring and mapping.
Interventions
DEVICEMINDZ Subdural Electrode Grid
The study intervention is limited to the insertion of the investigational device through the burr hole (up to 15 minutes), followed by an additional 5-minute recording using the device, resulting in a total extension of approximately 20 minutes to the standard surgical procedure. The data recorded using the investigational device will not be used for clinical decision-making. Following completion of the recording, the device will be removed through the burr hole, and the surgery will proceed according to the standard clinical protocol.
Sponsors
Neurosoft Bioelectronics SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤75 years at the time of enrolment. * Patients diagnosed with a brain tumour or epilepsy who require neurosurgical intervention. This includes patients undergoing craniotomy for brain surgery without the need for intracranial electrode monitoring, as well as patients undergoing neurosurgery with intraoperative neurophysiological monitoring using subdural electrodes. Specifically, this includes patients for whom subdural strip electrodes are indicated and planned to be implanted through standard-size burr holes (e.g., for phase-reversal evaluation) * Participants capable and willing to provide informed consent for participation in the trial.
Exclusion criteria
* History of significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol. * Any medical condition that contradicts neurosurgical intervention (i.e., acute or ongoing untreated infections, anticoagulant medication that cannot be discontinued, factor XIII deficiency or any other hematological disease). * Participation in another clinical study. * Known intolerances to the materials used in the soft device (medical grade silicone or platinum). * Vulnerable subject groups (e.g., pregnancy or lactation, prisoners, etc.). * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the MINDZ Subdural Electrode Grid | during the intraoperative procedure and up to 30days follow up | Incidence of device-emergent adverse events (SADE and ADE), assessed during the intraoperative procedure, post-procedurally, up to hospital discharge, and at the 30-day follow-up call. Acceptance criterion: No SADEs or ADEs observed in any patient. |
| Functional Performance of the MINDZ Subdural Electrode Grid | during the intraoperative procedure (post-deployment) | Device functionality following deployment, evaluated based on impedance measurements across all electrode contacts, assessed during the intraoperative procedure Acceptance criterion: Acceptable impedance values (\<30 kΩ) achieved in at least 75% of electrode channels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | up to 7 days post-intervention | User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention |
| Evaluation of haptic feedback during insertion and deployment | up to 7days post-intervention | Operator-reported ratings of haptic feedback during insertion and deployment, collected via questionnaire (e.g., force perception, resistance, and tactile response) |
| Procedural time assessment | during intraoperative procedure | — |
| Technical difficulties and device deficiencies (DDs) | during intraoperative procedure | — |
Countries
Switzerland
Contacts
CONTACTClinical and Regulatory Affairs Manager
Outcome results
None listed