Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство TDCS sham-stimulation
  TDCS sham-stimulation

Первичные конечные точки

• 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 [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (1)

• Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Публикации

• 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. PMID 36661376
• 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. PMID 35217351

Идентификаторы

NCT: NCT06344338 · Z211100002921030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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