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IRCT20230209057371N1 IRCT 2023-10-21 Shiraz University of Medical Sciences Evaluation of the effect of intracranial direct current in patients with seizures Evaluating the effectiveness of transcranial direct current stimulation (tDCS) in the management of patiants with super-refractory status epilepticus: A randomized clinial trial study 2023-10-02 anticipated 20 Complete https://irct.ir/trial/68601 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by using the block method of 20 pieces of paper written: TCDS and on the other 20 pieces "No intervention" will be written. Then all the crumpled papers will be poured into a container and mixed. Then, they will be taken out one by one and entered into the list from number 1 to 40. After that, forty sealed envelopes, which will be numbered up to 40 on the back, and the corresponding intervention method written inside each one, will be kept in the department's closet, and when each patient enters the study, the corresponding envelope will open in order and According to the written text, appropriate action will be taken. 3 super-refractory status epilepticus. Intervention 1: Intervention group: Patients whose seizures did not stop 24 hours after general anesthesia despite receiving standard seizure treatment drugs (intervention number 2) receive twice intracranial direct current stimulation by operating the relevant leads for 20 minutes at the rate of 2 milliamps, electrical stimulation will be done once in F4 and T5 areas and once again in the opposite side header in F3 and T6 areas. Intervention 2: All patients in each group will receive standard seizure treatments as usual (usually benzodiazepine drugs are used in the first stage of treatment.) If the seizures do not stop, intravenous anticonvulsants such as fennel are used in the next stage. Tween, levotirastam or valproate are used. If after two hours there is still evidence of continued seizures despite the steps 1 and 2, the patient will be put under general anesthesia and there will be no interruption in their usual treatment process. Intervention 3: Intervention group: History, physical examination, and blood sample for ca, Mg, phosphorus, BUN, Cr for the diagnosis and evaluation. No - There is not a plan to make this available Justification or reason for not sharing IPD is "there is no further information"
public Maryam Rohani
Namazi Hospital- Namazi square
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3647 4968 rohani_maryam96@yahoo.com Shiraz University of Medical Sciences scientific Maryam Rohani
Namazi Hospital- Namazi square
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3647 4968 rohani_maryam96@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) patients aged 18 to 70 years patients diagnosed with super refractory status epilepticus type of tonic-clonic seizure admitted to the cardiopulmonary resuscitation (CPR) ward or the emergency room of Namazi Hospital, Shiraz, Iran. 18 years 70 years Both Psychological seizures or Suffering from major psychological diseases Drug addiction Metabolic diseases causing seizures Pregnancy Skull abnormalities The existence of other electrical devices for the treatment of various diseases G40.803 Other epilepsy, intractable, with status epilepticus Treatment - Other Treatment - Drugs Diagnosis Intervention group: Patients whose seizures did not stop 24 hours after general anesthesia despite receiving standard seizure treatment drugs (intervention number 2) receive twice intracranial direct current stimulation by operating the relevant leads for 20 minutes at the rate of 2 milliamps, electrical stimulation will be done once in F4 and T5 areas and once again in the opposite side header in F3 and T6 areas. All patients in each group will receive standard seizure treatments as usual (usually benzodiazepine drugs are used in the first stage of treatment.) If the seizures do not stop, intravenous anticonvulsants such as fennel are used in the next stage. Tween, levotirastam or valproate are used. If after two hours there is still evidence of continued seizures despite the steps 1 and 2, the patient will be put under general anesthesia and there will be no interruption in their usual treatment process. Intervention group: History, physical examination, and blood sample for ca, Mg, phosphorus, BUN, Cr for the diagnosis and evaluation Evaluate the change in the convulsive movements. Timepoint: From the beginning of the seizure and its end till 24 hours. Method of measurement: By physical examination and direct observation of the presence or absence of any tonic, clonic, and myoclonic convulsive movements of the patient by the neurology assistant. Epileptiform waves in the electroencephalography (EEG). Timepoint: 30 minutes before and after the intervention. Method of measurement: Electroencephalograph. Shiraz University of Medical Sciences Approved 2023-04-16 Ethics committee of Shiraz University of Medical Sciences Zand str., Shiraz medical school Shiraz Fars Iran (Islamic Republic of)