Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus (NCT05934903) | Clinical Trial Compass
TerminatedNot Applicable
Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus
Stopped: Unable to meet adequate enrolment numbers for feasibility.
United States4 participantsStarted 2023-08-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment capability of the study site- Incidence
Timeframe: up to 24 months
2
Recruitment capability of the study site- Prevalence
Timeframe: up to 24 months
3
Recruitment capability of the study site- Percent Eligible
Timeframe: up to 24 months
4
Recruitment capability of the study site- Percent Consent
Timeframe: up to 24 months
5
Recruitment capability of the study site- Percent Withdraw