Application of tDCS Stimulation in Controlling Refractory Status Epilepticus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tDCS stimulation, TDCS sham-stimulation.
- Who it may be relevant to
- Registry conditions: Refractory Status Epilepticus. Basic parameters: 14 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus
Overview
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.
Interventions
- Device tDCS stimulation
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 - Device TDCS sham-stimulation
TDCS sham-stimulation
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
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. PMID 36661376
- Rezakhani 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. PMID 35217351
Identifiers
NCT: NCT06344338 · Z211100002921030