MINDZ-- Minimally Invasive Approach Pilot Study

NCT07543406 | Not Yet Recruiting

• 1 other identifier: CIP-04012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Neurophysiological Monitoring

Keywords

cortical electrode; IONM

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  during the intraoperative procedure (post-deployment)

Secondary Outcomes (4)

• Usability

  up to 7 days post-intervention

• Evaluation of haptic feedback during insertion and deployment

  up to 7days post-intervention

• Procedural time assessment

  during intraoperative procedure

• Technical difficulties and device deficiencies (DDs)

  during intraoperative procedure

Study Arms (1)

MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological Monitoring

EXPERIMENTAL

This is a single arm study with no comparator. The MINDZ subdural electrode will be used in addition to the standard of care work flow.

Device: MINDZ Subdural Electrode Grid

Interventions

MINDZ Subdural Electrode Grid DEVICE

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.

MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological Monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurosoft Bioelectronics SA: lead

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Central Study Contacts

Clinical and Regulatory Affairs Manager

CONTACT

+41762190000; clinical@neurosoft-bio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)