Refractory Status EpilepticustDCSNCT06344338
Application of tDCS Stimulation in Controlling Refractory Status Epilepticus
A study testing tDCS stimulation in people with Refractory Status Epilepticus, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Refractory Status Epilepticus
- What is being tested?
- tDCS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 14 and 80 year-old with Gender unlimited,
- Suitable for EEG monitoring;
- Clinical diagnosis of Refractory status epilepticus (status epilepticus that cannot be controlled by two types of antiepileptic drugs and at least one anesthetic);
- Informed consent to participate in this study was obtained from the participants or their surrogates
Who cannot join
- Unstable vital signs (systolic blood pressure<90mmHg, heart rate<60 beats/min, pulse oxygen saturation<90%);
- Having severe skull injury/defect or medical equipment implanted in the head;
- Pregnancy;
- With any implantable electronic instrument (including pacemakers, vagus nerve stimulators) or metal implanted devices.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
research centre of Xuanwu hospital Capital Medical University contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Weibi Chen, +8615010255903, chenweibi@126.com
About this study
Official title: Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus
The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus
Read the detailed description
After being informed about the study and potential risks, the recruited patients, giving written informed consent, will be determined of the eligibility for study entry. The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation.
- Conditions
- Refractory Status Epilepticus
- Being tested
- tDCS stimulation, TDCS sham-stimulation
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulationDevice
In the real-stimulation group, Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10. In the sham-stimulation group, The duration and frequency of tDCS are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation
TDCS sham-stimulationDevice
TDCS sham-stimulation
| Study group | Role | What they receive |
|---|---|---|
| tDCS treatment group | Experimental | In the real tDCS stimulation group, direct cathodal current at 2 mA was delivered by a tDCS device over the seizure onset zone. Anode was on the contralateral forehead. Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10. Receives: Device: tDCS stimulation |
| TDCS sham-stimulation group | Sham comparator | The duration and frequency of tDCS treatments in the sham-stimulation group are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation. Receives: Device: TDCS sham-stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus
Outcomes will be assessed by clinical observation and EEG evaluation before 10 times of tDCS stimulation between both groups
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group
Treatment-emergent adverse events will be assessed by clinical observation between tDCS treatment group and tDCS sham--stimulation group
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory Status EpilepticusStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibi Chen, Xuanwu Hospital, Beijing
- Investigators
- Weibi Chen, Dr, Study director, Xuanwu Hospital, BeijingJiaqing Yan, Dr, Principal investigator, College of Electrical and Control Engineering, North China University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344338
- Sponsor's protocol ID
- Z211100002921030
- Acronym
- tDCS
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is an exploratory study, and the important information is the signal analysis of electroencephalogram (EEG). However, these data were huge, which makes it difficult to export, save and upload. Meanwhile, the EEG data also require special softwares to read after being exported
Publications
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 36661376Rezakhani S, Amiri M, Weckhuysen S, Keliris GA. Therapeutic efficacy of seizure onset zone-targeting high-definition cathodal tDCS in patients with drug-resistant focal epilepsy. Clin Neurophysiol. 2022 Apr;136:219-227. doi: 10.1016/j.clinph.2022.01.130. Epub 2022 Feb 3.
PubMed 35217351
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus
- ClinicalTrials.gov ID
- NCT06344338
- Acronym / sponsor ID
- tDCS / Z211100002921030
- Conditions
- Refractory Status Epilepticus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus
Detailed description
After being informed about the study and potential risks, the recruited patients, giving written informed consent, will be determined of the eligibility for study entry. The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation
| Arm | Type | Receives |
|---|---|---|
| tDCS treatment group | Experimental | Device: tDCS stimulationIn the real tDCS stimulation group, direct cathodal current at 2 mA was delivered by a tDCS device over the seizure onset zone. Anode was on the contralateral forehead. Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10. |
| TDCS sham-stimulation group | Sham comparator | Device: TDCS sham-stimulationThe duration and frequency of tDCS treatments in the sham-stimulation group are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 14 and 80 year-old with Gender unlimited,
- Suitable for EEG monitoring;
- Clinical diagnosis of Refractory status epilepticus (status epilepticus that cannot be controlled by two types of antiepileptic drugs and at least one anesthetic);
- Informed consent to participate in this study was obtained from the participants or their surrogates
Key exclusion criteria (4 listed)
- Unstable vital signs (systolic blood pressure<90mmHg, heart rate<60 beats/min, pulse oxygen saturation<90%);
- Having severe skull injury/defect or medical equipment implanted in the head;
- Pregnancy;
- With any implantable electronic instrument (including pacemakers, vagus nerve stimulators) or metal implanted devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS stimulationIn the real-stimulation group, Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10. In the sham-stimulation group, The duration and frequency of tDCS are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation | Device | tDCS treatment group |
| TDCS sham-stimulationTDCS sham-stimulation | Device | TDCS sham-stimulation group |
Primary outcome
Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus
Time frame: through study completion, an average of 1 year
Outcomes will be assessed by clinical observation and EEG evaluation before 10 times of tDCS stimulation between both groups
1 secondary outcome
Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Results publication: PubMed 36661376Fisher 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.
- Results publication: PubMed 35217351Rezakhani S, Amiri M, Weckhuysen S, Keliris GA. Therapeutic efficacy of seizure onset zone-targeting high-definition cathodal tDCS in patients with drug-resistant focal epilepsy. Clin Neurophysiol. 2022 Apr;136:219-227. doi: 10.1016/j.clinph.2022.01.130. Epub 2022 Feb 3.
- Individual participant dataSharing planned: No. This study is an exploratory study, and the important information is the signal analysis of electroencephalogram (EEG). However, these data were huge, which makes it difficult to export, save and upload. Meanwhile, the EEG data also require special softwares to read after being exported
Related trials for Refractory Status Epilepticus
Not yet recruitingObservational study
Predictors of Outcomes of Convulsive Status Epilepticus
Status Epilepticus, Convulsive Status Epilepticus
Recruiting
EEG Monitoring for Refractory Status Epilepticus
Status Epilepticus
Not yet recruitingPhase 3
COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE"
New Onset Refractory Status Epilepticus, New-Onset Refractory Status Epilepticus
RecruitingPhase 2
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Hypoxia-Ischemia, Brain, Heart Arrest
Recruiting
KD Treatment for Super-refractory Status Epilepticus
Super-refractory Status Epilepticus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
research centre of Xuanwu hospital Capital Medical University contact
Weibi Chen, Dr study director
Xuanwu Hospital, Beijing
Jiaqing Yan, Dr principal investigator
College of Electrical and Control Engineering, North China University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation in people with Refractory Status Epilepticus, run by Xuanwu Hospital, Beijing at 1 site in China.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact research centre of Xuanwu hospital Capital Medical University (+8601083198899 ext. 8270, liugangqingyi@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus (time frame: through study completion, an average of 1 year). 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 NCT06344338, which also lists 2 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 Aug 2026.