Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT06205160
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06205160
Study Brief:
Protocol Section:
NCT06205160