Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Refractory Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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tDCS treatment group

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.

Group Type EXPERIMENTAL

tDCS stimulation

Intervention Type DEVICE

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 group

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.

Group Type SHAM_COMPARATOR

TDCS sham-stimulation

Intervention Type DEVICE

TDCS sham-stimulation

Interventions

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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

Intervention Type DEVICE

TDCS sham-stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No