New flexible brain electrodes tested during focal epilepsy surgery
Tests a new flexible brain electrode grid against standard grids in adults with focal epilepsy.
Plain-language title generated from the registry record
Registry title: Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Key facts
- Where
- Utrecht, NetherlandsSee the site
Where in Netherlands
- University Medical Center (UMC) UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurosoft Bioelectronics SA
- Trial code
- NCT06205160
- Record updated
- 10 December 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Planned ioECoG recordings during fully awake surgery and/or functional recordings; Active participation in another investigational device study; Use of anticoagulants that cannot be discontinued during the perioperative period, or a factor XIII deficiency or any other haematological disease; 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; Occipital lesion; Surgeries involving a primary mesial temporal lesion, a disconnection, or hemispherectomy; Insufficient understanding of Dutch language.