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:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT05934903
Eligibility Criteria:
Inclusion Criteria:
* Patient with refractory status epilepticus (RSE), or supra-refractory status epilepticus (SRSE), or electroencephalographic (EEG) characteristics \> 50% of the time on the ictal-interictal continuum (IIC) or epilepsia partialis continua for at least 12 hours.
* A patient with RSE is defined as having seizure(s) refractory to first line benzodiazepines and second-line antiseizure medications (ASMs; phenytoin, levetiracetam, valproate).
* A patient with SRSE is defined as:
* requiring at least 24 hours of a third-line intravenous anesthetic therapy (IVAT) such as propofol, midazolam, or ketamine, and
* failing at least one previous wean of an IVAT.
* A patient with epilepsia partialis continua (EPC) is defined as:
* having focal seizure(s) refractory to first line benzodiazepines and second-line ASMs and
* repeated episodes lasting more than one hour
* A patient on the IIC is defined as:
* having periodic discharges or rhythmic patterns at a rate at more than 1Hz and less than 3Hz and
* IIC patterns for more than 50% of the time (IIC burden = 50%) within any prior 12 hour interval.
* access to continuous EEG monitoring
* brain imaging (Computerized Tomography or Magnetic Resonance Imaging) within 1 year of presentation
Exclusion Criteria:
* Damaged skin on scalp as determined by the primary team that prevents reasonably accurate electroencephalography monitoring and which may interfere with tDCS stimulation.
* Cranial metal implants (\>1 mm thick epicranial titanium skull plates and metal dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant).
* Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
* Presence of any disease, medical condition or physical condition that, in the opinion of the Investigators, may adversely impact the safety of the subject or the integrity of the data
* Those who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05934903
Study Brief:
Protocol Section:
NCT05934903