Evaluation of new flexible high-density electrodes for epilepsy surgery
Official title: The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
Run by Neurosoft Bioelectronics SA · NCT06205160 · Data updated 2026-11-12
This study is testing new flexible electrode grids during epilepsy surgery to see if they can help improve the accuracy of the procedure for patients with lesional epilepsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Neurosoft Bioelectronics SA Industry-sponsored |
| Locations | 1 site (Utrecht) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT06205160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with lesional epilepsy who require intra-operative high-density grid recordings.
✕Probably not a fit
Patients with prior brain surgery, multiple epileptic foci, or those requiring awake surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical investigation aims to assess the feasibility and performance of flexible high-density SOFT ECoG electrode grids compared to standard high-density electrode grids used during epilepsy surgery. Participants will undergo additional intracranial recordings before and after resection using the new electrode grids alongside standard recordings. The study focuses on patients with lesional epilepsy who are candidates for intra-operative monitoring. The goal is to improve the precision of epilepsy surgery through advanced electrode technology.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of epilepsy surgeries, potentially leading to better patient outcomes.
How similar studies have gone: Other studies have shown promise in using advanced electrode technologies for epilepsy monitoring, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where it's running
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University Medical Center (UMC) Utrecht
Utrecht, Netherlands Recruiting
Study contacts
- Study coordinator: Karolina Janikowska Clinical Affairs Manager, PhD
- Email: karolina.janikowska@neurosoft-bio.com
- Phone: 000 000-0000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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High-density flexible microneuroelectrode mapping to guide epilepsy surgery
This study tests whether using high-density flexible microelectrocorticography during surgery helps guide the resection of the epileptogenic zone in people with drug-resistant focal epilepsy.
-
RAP-219 for adults with focal seizures
This study tests whether RAP-219 can reduce how often focal seizures happen in adults with focal epilepsy, compared with a placebo.
-
Spatial scene memory testing for people with temporal lobe epilepsy having surgery
This project tests whether a virtual tour memory task combined with brain recordings can show how adults with temporal lobe epilepsy recognize and recall places.
-
RAP-219 in adults with focal seizures
This study tests whether RAP-219 can safely reduce the number of focal seizures in adults with focal epilepsy compared with placebo.
-
Probenecid for cluster seizures during presurgical epilepsy monitoring
This trial tests whether probenecid can help control clusters of seizures in people with focal epilepsy during presurgical video-EEG monitoring.
-
Breath sound monitoring during general anesthesia
This project will test whether continuous electronic stethoscope monitoring during general anesthesia can help detect abnormal breathing and support safer respiratory care for adults having elective surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.