MINDZ-- Minimally Invasive Approach Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNeurosoft Bioelectronics SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
MINDZ Subdural Electrode Grid
DeviceThe 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: MINDZ Subdural Electrode Grid for Intraoperative Neurophysiological MonitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 up2
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)Secondary outcomes
1
Usability
User-reported device usability, assessed via questionnaire completed by each participating neurosurgeon following the intervention
Time frame
up to 7 days post-intervention2
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-intervention3
Procedural time assessment
Time frame
during intraoperative procedure4
Technical difficulties and device deficiencies (DDs)
Time frame
during intraoperative procedureSponsors and contacts
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Source ClinicalTrials.gov
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