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IRCT20200517047483N2 IRCT 2022-03-16 Shiraz University of Medical Sciences The evaluation of the effectiveness of transcranial direct current stimulation (tDCS) in the management of super-refractory convulsive status epilepticus The evaluation of the effectiveness of adjunctive application of transcranial direct current stimulation (tDCS) in the management of patients with super-refractory convulsive status epilepticus 2022-02-20 anticipated 20 Complete https://irct.ir/trial/61776 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Super-refractory convulsive status epilepticus. Intervention 1: control group: Control group: Patients with super-refractory convulsive status epilepticus who will receive all standard treatments for status epilepsy as follows: Normally, benzodiazepines (diazepam or lorazepam, CHEMIDAROU.Co) are used in the first line of treatment. If the seizure does not stop, in the next step, intravenous anticonvulsants such as phenytoin ( Caspian Tamin Co), levetiracetam (COBEL DAROU Co), or intravenous valproate (RAHA Co) are used, and if there is still evidence that the seizure persists after two hours despite treatment steps 1 and 2, the patient will be placed under general anesthesia. Intervention 2: Intervention group: Patients with super-refractory convulsive status epilepticus who will continue their seizures after receiving the standard treatment for seizures will be electrically stimulated through the skull with tDCS. In this way, after installing the relevant leads in the T5 and F4 areas, they will receive an electrical excitation of 2 mA for 20 minutes and the same amount of electrical excitation on the opposite side in the T6 and F3 areas for 20 minutes. Additionally, they will have an electroencephalogram 30 minutes prior to and 30 minutes following electrical stimulation. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD is to be shared. When: Starting 6 months after publication To whom: People working in academic institutions Conditions: To help further research to improve the treatment of refractory temporal lobe epilepsy Where to obtain: Marzie salimi- Salimi.md67@gmail.com How to obtain: Send their request to the mentioned email address and within one working week, if there is no problem, the data will be sent to them. Comments:
public Marzie Salimi
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5840 Salimi.md67@gmail.com Shiraz University of Medical Sciences scientific Marzie Salimi
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5840 Salimi.md67@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Male or female (non-pregnant female) patients between the ages of 18 and 70 years Patients with a diagnosis of super-refractory convulsive status epilepticus 18 years 70 years Both Patients with major psychiatric diseases Drug addiction Seizures are caused by metabolic abnormalities. pregnancy cranial defects The existence of additional electrical devices used to treat a variety of disorders Psychologic nonepileptic seizures G40.911 Epilepsy, unspecified, intractable, with status epilepticus Treatment - Other Treatment - Other control group: Control group: Patients with super-refractory convulsive status epilepticus who will receive all standard treatments for status epilepsy as follows: Normally, benzodiazepines (diazepam or lorazepam, CHEMIDAROU.Co) are used in the first line of treatment. If the seizure does not stop, in the next step, intravenous anticonvulsants such as phenytoin ( Caspian Tamin Co), levetiracetam (COBEL DAROU Co), or intravenous valproate (RAHA Co) are used, and if there is still evidence that the seizure persists after two hours despite treatment steps 1 and 2, the patient will be placed under general anesthesia. Intervention group: Patients with super-refractory convulsive status epilepticus who will continue their seizures after receiving the standard treatment for seizures will be electrically stimulated through the skull with tDCS. In this way, after installing the relevant leads in the T5 and F4 areas, they will receive an electrical excitation of 2 mA for 20 minutes and the same amount of electrical excitation on the opposite side in the T6 and F3 areas for 20 minutes. Additionally, they will have an electroencephalogram 30 minutes prior to and 30 minutes following electrical stimulation. Evaluation of the effectiveness of adjunctive use of intracranial direct current stimulation in reducing convulsive movements in patients with super-refractory status epilepticus. Timepoint: Evaluation of convulsive movements of patients before the intervention and 30 minutes after the intervention. Method of measurement: According to a neurology resident's direct observation and examination of the patients,. Evaluation of the effectiveness of adjunctive use of intracranial direct current stimulation in improving EEG in patients with super-refractory status epilepticus. Timepoint: Patients' levels of awareness were measured before and 30 minutes after the intervention. Method of measurement: According to the Glasgow Coma Scale. Evaluation of the effectiveness of adjunctive use of intracranial direct current stimulation in improving EEG in patients with super-refractory status epilepticus. Timepoint: Before and 30 minutes after the intervention, get an electroencephalogram. Method of measurement: electroencephalogram interpretation by a qualified and specialized epileptologist. Shiraz University of Medical Sciences Approved 2022-02-07 Medical Sciences Review Board and Ethics Committee (IRCT ) Namazi Sq., Zand St. Shiraz Fars Iran (Islamic Republic of)