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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05784805
Eligibility Criteria:
Inclusion Criteria:
* Subjects diagnosed with ongoing NCSE or FMSE despite treatment with at least 2 ASMs
* Provision of signed and dated informed consent form obtained from the next-of-kin/legally authorized representative
* Treated in the ICU while monitored with continuous scalp EEG electrodes
Exclusion Criteria:
* Unable to obtain informed consent
* Presence of an implanted cranial neuromodulation device for treatment of epilepsy
* Pregnancy
* Treatment with another investigational drug or other intervention within 24 hr
* Presence of burr hole(s) or craniotomy
* Subjects with ferromagnetic materials in the head
* Subjects with a TENS unit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT05784805
Study Brief:
Protocol Section:
NCT05784805