Clinical trial NCT06205160: Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Official title: The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Epilepsy
Intraoperative Monitoring
Keywords: intra-operative electrocorticography
HFO
epileptic biomarkers
high frequency oscillations
epilepsy surgery
flexible ECoG
subdural electrode
Lead sponsor: Neurosoft Bioelectronics SA
Sponsor class: INDUSTRY
Collaborators: name: UMC Utrecht
name: European Research Council
First posted: 2024-01-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years at the time of enrolment
* Lesional epilepsy (incl. mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent stereoelectroencephalography (SEEG) preceding resective surgery)
* Provided informed consent for study participation by the subject

Exclusion Criteria:

* Prior brain surgery (excl. SEEG)
* Occipital lesion
* Multiple epileptic foci or suspected dual pathology
* Surgeries involving a disconnection, or hemispherectomy.
* Planned 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.

Primary outcomes:
measure: Background SNR pre-resection recording
timeFrame: up to 24 hours
Secondary outcomes:
measure: Electrode deficiency ratio (%)
timeFrame: up to 24 hours
measure: Epileptic biomarker identification ( eg. number of spikes/HFOs per min, event SNR)
timeFrame: up to 24 hours
measure: Background SNR of post-resection recordings
timeFrame: up to 24 hours
measure: Surgical complications (e.g. SAEs/SADEs)
timeFrame: up to hospital discharge, on average at 10 days
measure: Usability evaluation
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center (UMC) Utrecht
Study officials:
References: