MINDZ-- Minimally Invasive Approach Pilot Study (MINDZ-MAP)

MINDZ-- Minimally Invasive Approach Pilot Study Single Center, First-in-Human Evaluation of MINDZ Electrode- Demonstrating the Feasibility of Safe, Burr-hole Deployment and Functional Efficacy

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 Overview

• Status: Not yet recruiting
• Conditions: Intraoperative Neurophysiological Monitoring
• Intervention / Treatment: Device: MINDZ Subdural Electrode Grid

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical and Regulatory Affairs Manager; Phone Number: +41762190000; Email: clinical@neurosoft-bio.com

Study Locations

• Switzerland
  • Zurich, Switzerland
    • University Hospital Zurich
    • Contact: Senior Physician, Department of Neurosurgery; Phone Number: 004100000000; Email: clinical@neurosoft-bio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological Monitoring; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention	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)	up to 7days post-intervention
Procedural time assessment		during intraoperative procedure
Technical difficulties and device deficiencies (DDs)		during intraoperative procedure

Collaborators and Investigators

• Sponsor: Neurosoft Bioelectronics SA

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IONM; cortical electrode
• Other Study ID Numbers: CIP-04012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No