Intraoperative Neurophysiological MonitoringMINDZ-MAPNCT07543406
MINDZ-- Minimally Invasive Approach Pilot Study
A study testing MINDZ Subdural Electrode Grid in people with Intraoperative Neurophysiological Monitoring, run by Neurosoft Bioelectronics SA at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intraoperative Neurophysiological Monitoring
- What is being tested?
- MINDZ Subdural Electrode Grid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Zurich
Zurich
Senior Physician, Department of Neurosurgery, 004100000000, clinical@neurosoft-bio.com
About this study
Official title: MINDZ-- Minimally Invasive Approach Pilot Study Single Center, First-in-Human Evaluation of MINDZ Electrode- Demonstrating the Feasibility of 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.
- Being tested
- MINDZ Subdural Electrode Grid
- Keywords
- cortical electrode, IONM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDZ Subdural Electrode GridDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MINDZ Subdural Electrode Grid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: during the intraoperative procedure (post-deployment)
Secondary outcomes (4)
Usability
User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention
Measured: 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)
Measured: up to 7days post-intervention
Procedural time assessment
Measured: during intraoperative procedure
Technical difficulties and device deficiencies (DDs)
Measured: during intraoperative procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Neurophysiological MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurosoft Bioelectronics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543406
- Sponsor's protocol ID
- CIP-04012
- Acronym
- MINDZ-MAP
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINDZ-- Minimally Invasive Approach Pilot Study Single Center, First-in-Human Evaluation of MINDZ Electrode- Demonstrating the Feasibility of Burr-hole Deployment and Functional Efficacy
- ClinicalTrials.gov ID
- NCT07543406
- Acronym / sponsor ID
- MINDZ-MAP / CIP-04012
- Keywords
- cortical electrode, IONM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Neurosoft Bioelectronics SAIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological Monitoring | Experimental | Device: MINDZ Subdural Electrode GridThis is a single arm study with no comparator. The MINDZ subdural electrode will be used in addition to the standard of care work flow. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINDZ Subdural Electrode GridThe 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. | Device | MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological Monitoring |
Primary outcome
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.
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
4 secondary outcomes
Usability
Time frame: up to 7 days post-intervention
Evaluation of haptic feedback during insertion and deployment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDZ Subdural Electrode Grid in people with Intraoperative Neurophysiological Monitoring, run by Neurosoft Bioelectronics SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical and Regulatory Affairs Manager (+41762190000, clinical@neurosoft-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the MINDZ Subdural Electrode Grid (time frame: during the intraoperative procedure and up to 30days follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.