Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

Not Applicable

Recruiting

• Conditions: Refractory Status Epilepticus
• Interventions: Device: tDCS stimulation; Device: TDCS sham-stimulation

• Registration Number: NCT06344338
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-27
• Study Start: 2024-04-01
• Study First Posted: 2024-04-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS treatment group	tDCS stimulation	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.
TDCS sham-stimulation group	TDCS sham-stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China