Focal EpilepsyEpiGridNCT06205160
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
A study testing SOFT ECoG subdural grid electrode in people with Focal Epilepsy and Intraoperative Monitoring, run by Neurosoft Bioelectronics SA at 1 site in Netherlands.
Trial summary
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy, Intraoperative Monitoring
- What is being tested?
- SOFT ECoG subdural grid electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of enrolment
- Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)
- Provided informed consent for study participation by the subject
Who cannot join
- Occipital lesion
- Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.
- Planned ioECoG recordings during fully awake surgery and/or functional recordings
- Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
- Active participation in another investigational device study
- Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study.
- Insufficient understanding of Dutch language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karolina Janikowska Clinical Affairs Manager, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center (UMC) Utrecht
Utrecht, 3584CX
Maryse van 't Klooster Study Coordinator, PhD
Dr. G.J.M. (Maeike) Zijlmans Prof. Dr.
About this study
Official title: The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.
Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.
- Conditions
- Focal Epilepsy, Intraoperative Monitoring
- Being tested
- SOFT ECoG subdural grid electrode
- Keywords
- intra-operative electrocorticography, HFO, epileptic biomarkers, high frequency oscillations, epilepsy surgery, flexible ECoG, subdural electrode
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFT ECoG subdural grid electrodeDevice
Test Device (SOFT ECoG subdural grid electrode): used for recording. During epilepsy surgery, in addition to standard clinical protocol (recording with comparator device), subjects will undergo ≥ 2 additional intracranial recordings with the SOFT ECoG flexible high density electrode grid (TD). Recording will be registered pre- and post-resection.
All procedures will be conducted according to standard clinical practice. Any medical decision making will be done using the standard of care CE-marked device (CD). The investigational, non-CE marked device is not used for clinical decision making.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Not described Receives: Device: SOFT ECoG subdural grid electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Background SNR pre-resection recording
Performance in terms of signal quality is assessed via background signal to noise ratio (SNR). Only channels which record properly based on visual inspection (no noise, no flat line) will be included in the background SNR calculation. For the pre-resection recordings (SITUATION I/I*), the background SNR per (included) channel and the average SNR for the electrode grid will be calculated, and pairwise comparison will be conducted between TD (SITUATION I*) and CD (SITUATION I).
Measured: up to 24 hours
Secondary outcomes (5)
Electrode deficiency ratio (%)
The individual electrodes will be classified, per recording, as poor or good signal quality based on visual criteria (i.e., noise, flat signal due to overlap with resection cavity or silicone of secondary electrode strip, pulsation artifacts). As a result, an electrode deficiency ratio (%) will be calculated as follows: # bad electrodes divided by the total # of electrodes per recording. This will be determined for the similar positioned CD recording (SITUATION I/II) to allow comparison with the TD (SITUATION I*/I**).
Measured: up to 24 hours
Epileptic biomarker identification ( eg. number of spikes/HFOs per min, event SNR)
After the surgery, spikes and high frequency oscilations (HFOs) will be visually marked in the final minute of the recording (note: assisted by automated spike/HFO detector) and checked by an expert. Marking of spikes and HFOs will be done in the TD and the corresponding CD recordings pre- and post-resection. Event rates (number of spikes/HFOs per minute) per channel and total per recording will be compared between the TD and CD. The average event SNR per channel and the average SNR per epileptogenic event type will be calculated per recording. The event SNR will be compared between the CD recording (SITUATION I/II) and the TD (SITUATION I*/I**).
Measured: up to 24 hours
Background SNR of post-resection recordings
The background SNR for post-resection recordings (SITUATION II/II) will be computed and pairwise compared. Note that it shall be considered that for the post-resection recordings (SITUATION II/II), in particular when measuring near/in the resection cavity, the performance of both the TD and CD for electrode deficiencies might differ significantly, positively and negatively.
Measured: up to 24 hours
Surgical complications (e.g. SAEs/SADEs)
The safety analysis will include surgical complications in terms of device deficiencies (DDs) and serious adverse events (SAEs), and whether these are device related (SADEs).
Measured: up to hospital discharge, on average at 10 days
Usability evaluation
A (digital) usability questionnaire (system usability scale + open questions) will be collected (within 48h after surgery).
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurosoft Bioelectronics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht, European Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205160
- Sponsor's protocol ID
- CIP-01202
- Acronym
- EpiGrid
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2023
- Last updated
- 10 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT06205160
- Acronym / sponsor ID
- EpiGrid / CIP-01202
- Conditions
- Focal Epilepsy, Intraoperative Monitoring
- Keywords
- intra-operative electrocorticography, HFO, epileptic biomarkers, high frequency oscillations, epilepsy surgery, flexible ECoG, subdural electrode
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Neurosoft Bioelectronics SAIndustry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht, European Research Council
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Jan 2024 (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.
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.
Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: SOFT ECoG subdural grid electrode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years at the time of enrolment
- Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent sEEG preceding resective surgery)
- Provided informed consent for study participation by the subject
Key exclusion criteria (7 listed)
- Occipital lesion
- Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy.
- Planned ioECoG recordings during fully awake surgery and/or functional recordings
- Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease
- Active participation in another investigational device study
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 |
|---|---|---|
| SOFT ECoG subdural grid electrodeTest Device (SOFT ECoG subdural grid electrode): used for recording. During epilepsy surgery, in addition to standard clinical protocol (recording with comparator device), subjects will undergo ≥ 2 additional intracranial recordings with the SOFT ECoG flexible high density electrode grid (TD). Recording will be registered pre- and post-resection. All procedures will be conducted according to standard clinical practice. Any medical decision making will be done using the standard of care CE-marked device (CD). The investigational, non-CE marked device is not used for clinical decision making. | Device | All subjects |
Primary outcome
Background SNR pre-resection recording
Time frame: up to 24 hours
Performance in terms of signal quality is assessed via background signal to noise ratio (SNR). Only channels which record properly based on visual inspection (no noise, no flat line) will be included in the background SNR calculation. For the pre-resection recordings (SITUATION I/I*), the background SNR per (included) channel and the average SNR for the electrode grid will be calculated, and pairwise comparison will be conducted between TD (SITUATION I*) and CD (SITUATION I).
5 secondary outcomes
Electrode deficiency ratio (%)
Time frame: up to 24 hours
Epileptic biomarker identification ( eg. number of spikes/HFOs per min, event SNR)
Time frame: up to 24 hours
Background SNR of post-resection recordings
Time frame: up to 24 hours
Surgical complications (e.g. SAEs/SADEs)
Time frame: up to hospital discharge, on average at 10 days
Usability evaluation
Time frame: up to 48 hours
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 Dec 2025.
- 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.
Karolina Janikowska Clinical Affairs Manager, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOFT ECoG subdural grid electrode in people with Focal Epilepsy and Intraoperative Monitoring, run by Neurosoft Bioelectronics SA at 1 site in Netherlands.
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 7 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. 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 Netherlands. 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 Karolina Janikowska Clinical Affairs Manager, PhD (000 000-0000, karolina.janikowska@neurosoft-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Background SNR pre-resection recording (time frame: up to 24 hours). 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 Dec 2025.