Evaluation of new flexible high-density electrodes for epilepsy surgery
The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
NA · Neurosoft Bioelectronics SA · NCT06205160
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neurosoft Bioelectronics SA (industry) |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06205160 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with lesional epilepsy who require intra-operative high-density grid recordings.
Not a fit: Patients with prior brain surgery, multiple epileptic foci, or those requiring awake surgery may not benefit from this study.
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 performed: Other studies have shown promise in using advanced electrode technologies for epilepsy monitoring, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Utrecht
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Focal Epilepsy, Intraoperative Monitoring, intra-operative electrocorticography, HFO, epileptic biomarkers, high frequency oscillations, epilepsy surgery, flexible ECoG