Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus

Trial details

Who runs it

Yale University

Trial code

NCT05934903

Record updated

4 April 2025

Original description

Status epilepticus, or recurrent seizures without return to baseline, is a neurologic emergency. Refractory status epilepticus occurs when seizures are resistant to multiple first line anti-seizure medications. The ability to quickly stop seizures is paramount. Transcranial direct current simulation is a non-invasive, easily administered therapy that can potentially help reduce seizure burden.Read full original descriptionShow less

Status epilepticus, or recurrent seizures without return to baseline, is a neurologic emergency. Refractory status epilepticus occurs when seizures are resistant to multiple first line anti-seizure medications. The ability to quickly stop seizures is paramount. Transcranial direct current simulation is a non-invasive, easily administered therapy that can potentially help reduce seizure burden.

The goal of this feasibility study is to assess the ability of the study site to enroll patients admitted with refractory seizures or those with abnormal brain wave patterns to take part in a study looking to use transcranial direct current stimulation as an adjunctive treatment. The main questions it aims to answer are:

* What is the recruitment capability of the study site? * How well can the study site adhere to study protocol? * Are there any adverse effects of using the transcranial direct current stimulation device? * How do patients' brain wave studies respond to the stimulation? Participants will be asked to consider joining the study. Once joined, researchers will randomly assign participants to compare transcranial stimulation versus sham stimulation to see if this will affect the participant's brain wave patterns.

Inclusion: 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: 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; 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); 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; Damaged skin on scalp as determined by the primary team that prevents reasonably accurate electroencephalography monitoring and which may interfere with tDCS stimulation; Those who are pregnant.

ClinicalTrials.gov NCT05934903