RecruitingNot ApplicableNCT06344338

Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

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


Sponsor

Xuanwu Hospital, Beijing

Enrollment

32 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 14 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

DEVICEtDCS 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

DEVICETDCS sham-stimulation

TDCS sham-stimulation


Locations(1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT06344338


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