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

Neurosoft Bioelectronics

Status: Enrolling

Conditions: Intraoperative Monitoring; Focal Epilepsy

Treatments: Device: SOFT ECoG subdural grid electrode

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06205160

CIP-01202

Details and patient eligibility

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

All subjects

Experimental group

Treatment:

Device: SOFT ECoG subdural grid electrode