Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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:

1. Screening and Consent visit
2. Stimulation Sessions - 3 one-hour stimulation sessions, distributed over 72 consecutive hours, and no less than 24 hours apart.
3. Follow up visit at 30 days after intervention.

Conditions

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Status Epilepticus Refractory Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind block randomized into stimulation arm versus sham stimulation arm.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participant will not know the treatment arm, and the outcomes assessor reading electroencephalogram will not know treatment arm. The device does not have a sham mode so study personnel applying the device will be aware of the treatment arm.

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Cathodal direct current stimulation at 0 or 2mA will be applied to subjects

Sham 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.

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Cathodal direct current stimulation at 0 or 2mA will be applied to subjects

Interventions

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Transcranial Direct Current Stimulation

Cathodal direct current stimulation at 0 or 2mA will be applied to subjects

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No