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Status EpilepticusNCT05934903

Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus

A study testing Transcranial Direct Current Stimulation in people with Status Epilepticus and Refractory Status Epilepticus, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteUnited States
Study dates
31 Aug 2023to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

Other trials in United States

About this study

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.
Read the detailed description

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.
Keywords
Transcranial Direct Current Stimulation, Ictal-Interictal Continuum, Neurostimulation, Seizures, Epilepsy
Medical subject headings
Status Epilepticus, Seizures, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05934903
Study groupRoleWhat they receive
StimulationExperimentalThe 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.
Receives: Device: Transcranial Direct Current Stimulation
Sham StimulationSham comparatorThe 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.
Receives: Device: Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 24 months

  2. 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.

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

  4. 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

    Measured: up to 24 months

  5. 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.

    Measured: up to 24 months

Secondary outcomes (12)

  1. 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.

    Measured: up to 24 months

  2. 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.

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

  4. 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.

    Measured: up to 24 months

  5. Safety profile of tDCS by number of adverse events.

    Safety profile of tDCS will be assessed as the number of adverse events.

    Measured: up to 24 months

  6. Safety profile of tDCS by number of serious adverse events.

    Safety profile of tDCS will be assessed as the number of serious adverse events.

    Measured: up to 24 months

  7. 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.

    Measured: Baseline, 12 hours, 24 hours, 7 days, and 30 days

  8. 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.

    Measured: Baseline, 12 hours, 24 hours, 7 days, and 30 days

  9. 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.

    Measured: Baseline, 12 hours, 24 hours, 7 days, and 30 days

  10. 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).

    Measured: Baseline, 12 hours, 24 hours, 7 days, and 30 days

  11. 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.

    Measured: Baseline and 7 days

  12. 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.

    Measured: Baseline and 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start31 Aug 2023
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Why it stopped: Unable to meet adequate enrolment numbers for feasibility.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind block randomized into stimulation arm versus sham stimulation arm.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934903
Sponsor's protocol ID
2000035450
Other IDs
No NIH funding
Status last verified
Mar 2025
First submitted
28 Jun 2023
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trinka E, Rainer LJ, Granbichler CA, Zimmermann G, Leitinger M. Mortality, and life expectancy in Epilepsy and Status epilepticus-current trends and future aspects. Front Epidemiol. 2023 Feb 23;3:1081757. doi: 10.3389/fepid.2023.1081757. eCollection 2023.

    PubMed 38455899

  • Fisher RS, McGinn RJ, Von Stein EL, Wu TQ, Qing KY, Fogarty A, Razavi B, Venkatasubramanian C. Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting. Epilepsia. 2023 Apr;64(4):875-887. doi: 10.1111/epi.17514. Epub 2023 Feb 7.

    PubMed 36661376

  • Ng MC, El-Alawi H, Toutant D, Choi EH, Wright N, Khanam M, Paunovic B, Ko JH. A Pilot Study of High-Definition Transcranial Direct Current Stimulation in Refractory Status Epilepticus: The SURESTEP Trial. Neurotherapeutics. 2023 Jan;20(1):181-194. doi: 10.1007/s13311-022-01317-5. Epub 2022 Nov 2.

    PubMed 36323975

  • Matsumoto H, Ugawa Y. Adverse events of tDCS and tACS: A review. Clin Neurophysiol Pract. 2016 Dec 21;2:19-25. doi: 10.1016/j.cnp.2016.12.003. eCollection 2017.

    PubMed 30214966

  • Yang D, Wang Q, Xu C, Fang F, Fan J, Li L, Du Q, Zhang R, Wang Y, Lin Y, Huang Z, Wang H, Chen C, Xu Q, Wang Y, Zhang Y, Zhang Z, Zhao X, Zhao X, Li T, Liu C, Niu Y, Zhou Q, Zhou Q, Duan Y, Liu X, Yu T, Xue Q, Li J, Dai X, Han J, Ren C, Xu H, Li N, Zhang J, Xu N, Yang K, Wang Y. Transcranial direct current stimulation reduces seizure frequency in patients with refractory focal epilepsy: A randomized, double-blind, sham-controlled, and three-arm parallel multicenter study. Brain Stimul. 2020 Jan-Feb;13(1):109-116. doi: 10.1016/j.brs.2019.09.006. Epub 2019 Sep 24.

    PubMed 31606448

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Status Epilepticus and Refractory Status Epilepticus, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unable to meet adequate enrolment numbers for feasibility.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment capability of the study site- Incidence (time frame: up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05934903, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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