Refractory Status Epilepticus
Conditions
Brief summary
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
DEVICEtDCS 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
DEVICETDCS sham-stimulation
TDCS sham-stimulation
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group | through study completion, an average of 1 year | Treatment-emergent adverse events will be assessed by clinical observation between tDCS treatment group and tDCS sham--stimulation group |
Countries
China
Contacts
CONTACTresearch centre of Xuanwu hospital Capital Medical University
CONTACTJiaqing Tian, Dr
STUDY_DIRECTORWeibi Chen, Dr
Xuanwu Hospital, Beijing
PRINCIPAL_INVESTIGATORJiaqing Yan, Dr
College of Electrical and Control Engineering, North China University of Technology
Outcome results
None listed