Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus
Status Epilepticus, Refractory Status Epilepticus
About this trial
This is an interventional other trial for Status Epilepticus focused on measuring Transcranial Direct Current Stimulation, Ictal-Interictal Continuum, Neurostimulation, Seizures, Epilepsy
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
Sites / Locations
- Yale New Haven HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Stimulation
Sham Stimulation
The tDCS device will stimulate with a 2mA current during sessions. Both arms receive application of the device for 3 sessions of 2x 30 minute active application with 30 minutes rest in between.
The tDCS device will stimulate with a 0mA current during sessions (sham). Both arms receive application of the device for 3 sessions of 2x 30 minute active application with 30 minutes rest in between.