Actively Recruiting
The EpiGrid Study Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery
Led by Neurosoft Bioelectronics SA · Updated on 2025-12-10
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Neurosoft Bioelectronics SA
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new flexible high-density SOFT ECoG electrode grids designed for use during epilepsy surgery. This study compares the performance and feasibility of these new electrodes, made by Neurosoft Bioelectronics SA, with the regular high-density electrode grids currently used at the study site. The investigation focuses on patients with focal epilepsy undergoing intraoperative monitoring during surgery. Participants will have at least two extra intracranial recordings taken with the SOFT ECoG flexible electrode grids before and after the surgical removal of brain tissue. These recordings are done alongside the standard recordings made with the currently approved device. The investigational device is used only for study recordings and does not influence clinical decisions, which are based on the standard CE-marked device. During the study, researchers will measure the background signal-to-noise ratio (SNR) from recordings up to 24 hours before surgery, as well as electrode performance, detection of epileptic biomarkers like spikes, and post-surgery recordings. They will also monitor surgical complications until hospital discharge, usually about 10 days after surgery, and evaluate device usability within 48 hours. Participants will be involved during the surgery and monitoring periods, with data collected through standard clinical procedures.
CONDITIONS
Brief Title
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrolment
- Diagnosed with lesional epilepsy, including secondary mesial temporal sclerosis, and considered a candidate for intra-operative high-density grid recordings
- Provided informed consent for study participation
You will not qualify if you...
- Presence of an occipital lesion
- Surgeries involving primary mesial temporal lesion, disconnection, or hemispherectomy
- Planned intraoperative ECoG recordings during fully awake surgery or functional recordings
- Use of anticoagulants that cannot be stopped during the perioperative period, or having factor XIII deficiency or other hematological diseases
- Active participation in another investigational device study
- Any condition that may affect safety or ability to complete the study as judged by the investigator
- Insufficient understanding of the Dutch language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to hospital discharge, on average 10 days
Participants undergo epilepsy surgery during which the new flexible high-density intra-operative ECoG electrodes are used alongside the standard clinical electrodes to record brain activity before and after resection. All procedures follow standard clinical practice, and any medical decisions are made using the standard of care devices.
1 surgery visit and post-operative monitoring until discharge
Trial Site Locations
Total: 1 location
1
University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3584CX
Actively Recruiting
Research Team
K
Karolina Janikowska Clinical Affairs Manager, PhD
G
G.J.M. Zijlmans Study Principal Investigator, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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