Clinical trial NCT06344338: Application of tDCS Stimulation in Controlling Refractory Status Epilepticus
Official title: Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Status Epilepticus
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 32
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Weibi Chen, Dr
role: STUDY_DIRECTOR
affiliation: College of Electrical and Control Engineering, North China University of Technology
name: Jiaqing Yan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2022 Feb 3.