An interventional study of Transcranial Direct Current Stimulation in Status Epilepticus and Refractory Status Epilepticus, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Yale University · Not applicable, Interventional, and Device feasibility
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:
This is study is designed to determine the feasibility of implementing a double-blinded tDCS in inpatients with status epilepticus and other abnormal EEG (electroencephalography) patterns. The study includes assessments of recruitment capability, the ability to implement the study procedures, the safety profile, and preliminary evaluation of participant response to transcranial direct current stimulation (tDCS) therapy, to see which clinical outcome measures are most practical.
Patients who are admitted to Yale New Haven Hospital with refractory status epilepticus or EEG patterns falling on the ictal-interictal continuum (IIC, rhythmic or periodic patterns with rates more than 1Hz and less than or equal to 2.5Hz) will be recruited, starting from August 1st 2023 until July 31st 2025, or until 60 total participants, whichever is sooner. Those who are eligible will be randomized into two groups: stimulation or sham, all while receiving standard of care according to their primary teams.
Each subject will receive up to 3 sessions of tDCS over a 72 hour period with at least 24 hours between each session. Each session will consist of 30 minutes of stimulation (or sham), a 30 minute break and a second 30 minute of stimulation (or sham). Stimulation will be applied using the ActivaDose II device (Caputron). Saline soaked sponges will be prepared, with the cathode being placed on the area corresponding to the seizure focus or point of maximal epileptic potential as defined on the international 10-20 EEG system. The anode will be placed on the contralateral shoulder. During each session, a maximum of total injected current across the electrodes of 2mA will be used, as conventional tDCS with 2mA is well-tolerated in adults and children. Sham stimulation includes application of the electrodes and timing the device to deliver 0mA of injected current.
The patients will not be aware of their randomization arm. The research staff analyzing the EEG data will not be aware of the patient's treatment arm.
The study schedule will include:
126 studies on the registry are indexed under Status Epilepticus; 38 are open to participants now.
This study's enrollment of 4 is below the median of 70 across 74 interventional studies indexed under Status Epilepticus.
Browse Status Epilepticus studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 SRSE is defined as:
A patient with epilepsia partialis continua (EPC) is defined as:
A patient on the IIC is defined as:
Exclusion Criteria:
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.
Device: Transcranial Direct Current Stimulation
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.
Device: Transcranial Direct Current Stimulation
Cathodal direct current stimulation at 0 or 2mA will be applied to subjects
Recruitment capability of the study site- Incidence
Recruitment capability of the study site will be assessed as the incidence of patients admitted with RSE/SRSE or IIC burden \> 50% within a 24 month period. Participants admitted undergoing cEEG monitoring will be screened for having RSE or IIC burden \>50% on a weekly basis.
Time frame: up to 24 months
Recruitment capability of the study site- Prevalence
Recruitment capability of the study site will be assessed as the prevalence of patients admitted with RSE/SRSE or IIC burden \> 50% within a 24 month period. Participants admitted undergoing cEEG monitoring will be screened for having RSE or IIC burden \>50% on a weekly basis. Prevalence will be calculated against weekly average patient census.
Time frame: up to 24 months
Recruitment capability of the study site- Percent Eligible
Recruitment capability of the study site will be assessed as the percent of eligible study participants compared to all patients admitted with RSE or IIC burden \>50% within a 24-month period.
Time frame: up to 24 months
Recruitment capability of the study site- Percent Consent
Recruitment capability of the study site will be assessed as the percent of eligible participants who consent for study
Time frame: up to 24 months
Recruitment capability of the study site- Percent Withdraw
Recruitment capability of the study site will be assessed as the percent of consented participants who withdraw consent.
Time frame: up to 24 months
Ability to implement protocol at study site
Ability to implement protocol at the study site will be assessed as the percent of patients able to complete the stimulation protocol and drop out causes.
Time frame: up to 24 months
Ability to implement protocol at study site- Protocol Deviations
Ability to implement protocol at the study site will be assessed as the percent of protocol deviations including un-blinding, contamination, truncation or extension of stimulation protocol, and qualitative causes of protocol deviations.
Time frame: up to 24 months
Ability to implement protocol at study site- Participants Lost to Follow Up
Ability to implement protocol at the study site will be assessed as the percent of participants lost to follow up.
Time frame: up to 24 months
Ability to implement protocol at study site- Device Failures
Ability to implement protocol at the study site will be assessed as the percent of device failure compared to total number of stimulation sessions.
Time frame: up to 24 months
Safety profile of tDCS by number of adverse events.
Safety profile of tDCS will be assessed as the number of adverse events.
Time frame: up to 24 months
Safety profile of tDCS by number of serious adverse events.
Safety profile of tDCS will be assessed as the number of serious adverse events.
Time frame: up to 24 months
Preliminary evaluation of effect of tDCS- Change in Time to resolution of status epilepticus
Preliminary evaluation of the effect of tDCS on participants with RSE/SRSE or high IIC burden will be assessed as time to resolution of status epilepticus in patients admitted with RSE and SRSE (hours) in either study arm. Time to resolution of status epilepticus is defined as the time from first stimulation session until cessation of electrographic status epilepticus for more than 8 hours.
Time frame: Baseline, 12 hours, 24 hours, 7 days, and 30 days
Preliminary evaluation of effect of tDCS- Change in Seizure Burden
Preliminary evaluation of the effect of tDCS on participants with RSE/SRSE or high IIC burden will be assessed using EEG assessments to determine seizure burden before, during, and after intervention. Assesments will be conducted by study personnel on a post-hoc basis and quantified using both automatic spike detection software (Persyst) and manual methods.
Time frame: Baseline, 12 hours, 24 hours, 7 days, and 30 days
Preliminary evaluation of effect of tDCS- Change in IIC burden
Preliminary evaluation of the effect of tDCS on participants with RSE/SRSE or high IIC burden will be assessed using EEG assessments to determine IIC burden before, during, and after intervention. Assessments will be conducted by study personnel on a post-hoc basis and quantified using both automatic spike detection software (Persyst) and manual methods.
Time frame: Baseline, 12 hours, 24 hours, 7 days, and 30 days
Preliminary evaluation of effect of tDCS- Change in ASM burden
Preliminary evaluation of the effect of tDCS on participants with RSE/SRSE or high IIC burden will be assessed by the ASM burden at baseline, 12 hours, 7 days, and 30 days after intervention. Anti-seizure medication burden is defined as the sum total of all antiseizure medication ratios. Antiseizure medication ratios are defined as the prescribed total daily dose given over the maximal allowed daily dose of each given antiseizure medication as defined by the World Health Organization as the typical daily dose for a given ASM. ASM burden = Σ (ASM total daily dose/ASM total daily max dose).
Time frame: Baseline, 12 hours, 24 hours, 7 days, and 30 days
Preliminary evaluation of effect of tDCS- Change in Acute Physiology and Chronic Health Evaluation (APACHE) II Score
Preliminary evaluation of the effect of tDCS on participants with RSE/SRSE or high IIC burden will be assessed using the APACHE II Score. Each variable is weighted from 0 to 4, with the range of the total score from 0 to 71. Higher scores correspond to more severe disease and a higher risk of death.
Time frame: Baseline and 7 days
Preliminary evaluation of effect of tDCS- Change in modified Rankin Score
Preliminary evaluation of the effect of tDCS on participants with RSE/SRSE or high IIC burden will be assessed using the modified Rankin Score. It is a 6 point disability scale with possible scores ranging from 0 (no disability) to 5.(disability requiring constant care for all needs); 6 is death.
Time frame: Baseline and 30 days
Plan to share: No
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