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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
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.
University Hospital Zurich
Zurich, Switzerland
Safety of the MINDZ Subdural Electrode Grid
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.
Time frame: during the intraoperative procedure and up to 30days follow up
Functional Performance of the MINDZ Subdural Electrode Grid
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
Time frame: during the intraoperative procedure (post-deployment)
Usability
User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention
Time frame: up to 7 days post-intervention
Evaluation of haptic feedback during insertion and deployment
Operator-reported ratings of haptic feedback during insertion and deployment, collected via questionnaire (e.g., force perception, resistance, and tactile response)
Time frame: up to 7days post-intervention
Procedural time assessment
Time frame: during intraoperative procedure
Technical difficulties and device deficiencies (DDs)
Time frame: during intraoperative procedure
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