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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS treatment group | Experimental | 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. |
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| TDCS sham-stimulation group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS stimulation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| research centre of Xuanwu hospital Capital Medical University | Contact | +8601083198899 | 8270 | liugangqingyi@sina.com |
| Jiaqing Tian, Dr | Contact | +8615311415116 | smile21tian@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weibi Chen, Dr | Xuanwu Hospital, Beijing | Study Director |
| Jiaqing Yan, Dr | College of Electrical and Control Engineering, North China University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36661376 | Result | 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. | |
| 35217351 | Result |
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This study is an exploratory study, and the important information is the signal analysis of electroencephalogram (EEG). However, these data were huge, which makes it difficult to export, save and upload. Meanwhile, the EEG data also require special softwares to read after being exported
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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
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| TDCS sham-stimulation | Device | TDCS sham-stimulation |
|
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |