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

NCT06205160 | Recruiting

• 1 other identifier: CIP-01202
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

intra-operative electrocorticography; HFO; epileptic biomarkers; high frequency oscillations; epilepsy surgery; flexible ECoG; subdural electrode

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 24 hours

Secondary Outcomes (5)

• Electrode deficiency ratio (%)

  up to 24 hours

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

  up to 24 hours

• Background SNR of post-resection recordings

  up to 24 hours

• Surgical complications (e.g. SAEs/SADEs)

  up to hospital discharge, on average at 10 days

• Usability evaluation

  up to 48 hours

Study Arms (1)

All subjects

EXPERIMENTAL

Device: SOFT ECoG subdural grid electrode

Interventions

SOFT ECoG subdural grid electrode 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.

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Research Council: collaborator
• Neurosoft Bioelectronics SA: lead
• UMC Utrecht: collaborator

Study Sites (1)

University Medical Center (UMC) Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 12, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)