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

NCT ID: NCT06205160

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-03-31

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.

Conditions

Focal Epilepsy; Intraoperative Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All subjects

Group Type: EXPERIMENTAL

SOFT ECoG subdural grid electrode

Intervention Type: DEVICE

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.

Interventions

SOFT ECoG subdural grid electrode

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

European Research Council

OTHER

Sponsor Role: collaborator

Neurosoft Bioelectronics SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center (UMC) Utrecht

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Karolina Janikowska Clinical Affairs Manager, PhD

Role: CONTACT

karolina.janikowska@neurosoft-bio.com

000 000-0000

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

Role: CONTACT

G.J.M.Zijlmans@umcutrecht.nl

000 000-0000

Facility Contacts

Maryse van 't Klooster Study Coordinator, PhD

Role: primary

Other Identifiers

CIP-01202

Identifier Type: -

Identifier Source: org_study_id