Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

N/ARecruitingNCT06205160

Neurosoft Bioelectronics SA12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Focal Epilepsy Intraoperative Monitoring

Interventions

Test Device (SOFT ECoG subdural grid electrode): used for recording. During epilepsy surgery, in addition to standard clinical protocol (recording with comparator device), subjects will undergo ≥ 2 additional intracranial recordings with the SOFT ECoG flexible high density electrode grid (TD). Recording will be registered pre- and post-resection. All procedures will be conducted according to standard clinical practice. Any medical decision making will be done using the standard of care CE-marked device (CD). The investigational, non-CE marked device is not used for clinical decision making.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Background SNR pre-resection recording

Performance in terms of signal quality is assessed via background signal to noise ratio (SNR). Only channels which record properly based on visual inspection (no noise, no flat line) will be included in the background SNR calculation. For the pre-resection recordings (SITUATION I/I\*), the background SNR per (included) channel and the average SNR for the electrode grid will be calculated, and pairwise comparison will be conducted between TD (SITUATION I\*) and CD (SITUATION I).

Time frame: up to 24 hours

Secondary Outcomes

Electrode deficiency ratio (%)

The individual electrodes will be classified, per recording, as poor or good signal quality based on visual criteria (i.e., noise, flat signal due to overlap with resection cavity or silicone of secondary electrode strip, pulsation artifacts). As a result, an electrode deficiency ratio (%) will be calculated as follows: # bad electrodes divided by the total # of electrodes per recording. This will be determined for the similar positioned CD recording (SITUATION I/II) to allow comparison with the TD (SITUATION I\*/I\*\*).

Time frame: up to 24 hours

Epileptic biomarker identification ( eg. number of spikes/HFOs per min, event SNR)

After the surgery, spikes and high frequency oscilations (HFOs) will be visually marked in the final minute of the recording (note: assisted by automated spike/HFO detector) and checked by an expert. Marking of spikes and HFOs will be done in the TD and the corresponding CD recordings pre- and post-resection. Event rates (number of spikes/HFOs per minute) per channel and total per recording will be compared between the TD and CD. The average event SNR per channel and the average SNR per epileptogenic event type will be calculated per recording. The event SNR will be compared between the CD recording (SITUATION I/II) and the TD (SITUATION I\*/I\*\*).

Time frame: up to 24 hours

Background SNR of post-resection recordings

The background SNR for post-resection recordings (SITUATION II/II\*\*) will be computed and pairwise compared. Note that it shall be considered that for the post-resection recordings (SITUATION II/II\*\*), in particular when measuring near/in the resection cavity, the performance of both the TD and CD for electrode deficiencies might differ significantly, positively and negatively.

Time frame: up to 24 hours

Surgical complications (e.g. SAEs/SADEs)

The safety analysis will include surgical complications in terms of device deficiencies (DDs) and serious adverse events (SAEs), and whether these are device related (SADEs).

Time frame: up to hospital discharge, on average at 10 days

Usability evaluation

A (digital) usability questionnaire (system usability scale + open questions) will be collected (within 48h after surgery).

Time frame: up to 48 hours

Central Contacts

Karolina Janikowska Clinical Affairs Manager, PhD

CONTACT

000 000-0000 karolina.janikowska@neurosoft-bio.com

G.J.M. Zijlmans Study Principal Investigator, PhD

CONTACT

000 000-0000 G.J.M.Zijlmans@umcutrecht.nl

Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts