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NCT Number: NCT07543406

MINDZ-- Minimally Invasive Approach Pilot Study

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, Switzerland

Location contact

Senior Physician, Department of Neurosurgery

CONTACT

[email protected]

004100000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Safety of the MINDZ Subdural Electrode Grid

    Time frame: 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.

  2. Functional Performance of the MINDZ Subdural Electrode Grid

    Time frame: 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 outcomes

  1. Usability

    Time frame: up to 7 days post-intervention

    User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention

  2. Evaluation of haptic feedback during insertion and deployment

    Time frame: 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)

  3. Procedural time assessment

    Time frame: during intraoperative procedure

  4. Technical difficulties and device deficiencies (DDs)

    Time frame: during intraoperative procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical and Regulatory Affairs Manager

CONTACT

[email protected]

+41762190000

Sponsors and collaborators

Lead sponsor

Neurosoft Bioelectronics SA

Industry

Registry information

Official study title

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

Acronym: MINDZ-MAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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