Application of tDCS Stimulation in Controlling Refractory Status Epilepticus
ConditionRefractory Status Epilepticus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-80
SponsorXuanwu Hospital, Beijing
About this trial
The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
tDCS stimulation
DeviceIn 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-stimulation
DeviceTDCS sham-stimulation
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: tDCS treatment groupExperimental treatment 1 intervention
Group B: TDCS sham-stimulation groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 1 yearSecondary 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
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov