Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

Refractory Status Epilepticus Clinical Trial

— tDCS  

Official title:

Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344338
• Other study ID #: Z211100002921030
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Xuanwu Hospital, Beijing
• Contact: research centre of Xuanwu hospital Capital Medical University
• Phone: +8601083198899
• Email: liugangqingyi[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractory Status Epilepticus
• Status Epilepticus

Intervention

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
• TDCS sham-stimulation
TDCS sham-stimulation

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year