Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Recruiting · NCT06205160 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurosoft Bioelectronics SA
View the official record on ClinicalTrials.gov →Interventions studied
SOFT ECoG subdural grid electrode
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- University Medical Center (UMC) Utrecht - Utrecht, Netherlands