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IRCT20200111046082N2 IRCT 2020-04-10 Kerman University of Medical Sciences Determining the Efficacy of Brain Electrical Stimulation in Shortening the Hospitalization of Patients With drug resistant epilepsy The Efficacy of High Definition anodal transcranial direct current stimulation in shortening of duration of hospitalization in Epilepsy Monitoring Unit of patients with drug-resistant epilepsy 2020-06-20 anticipated 40 Complete https://irct.ir/trial/46771 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients were randomly divided into two groups of 20 each. Randomization was performed using random sequencing with the help of SAS statistical software. Patients were divided into treatment and control groups according to the order of entry based on this sequence. Sealed envelopes were used to hide random allocation, Blinding description: Patients, main investigator and data analyser were masked of patients allocation. patients did not know the name of group and treatments. we used Sham for patients in control group. all questionnaire completed in different periods without name and only the related nurse know the patients allocations. N/A drug resistant epilepsy. Intervention 1: Intervention group: Twenty patients diagnosed with drug-resistant epilepsy will be studied according to the definition of the International league against Epilepsy (ILAE) after approval by the Ethics and Signature of consent. In all patients with possible epileptogenic zone according to semiology. The patient's previous epilepsy and lumbar strips are localized, and epileptogenic lesions are diagnosed by MRI of the brain with epilepsy protocols. Their antiepileptic drugs are discontinued during hospitalization in the EMU. Participants are randomly assigned to the experimental or sham group. Ten participants (experimental group) performed HD a-tDCS intervention in a current of 2 mA to fashion. They receive 30 minutes on the second day of hospitalization in the EMU twice in 4 hours on the epileptogenic zone. Intervention 2: Control group: Twenty patients diagnosed with drug-resistant epilepsy will be studied according to the definition of the International league against Epilepsy (ILAE) after approval by the Ethics and Signature of consent. In all patients with possible epileptogenic zone according to semiology. The patient's previous epilepsy and lumbar strips are localized, and epileptogenic lesions are diagnosed by MRI of the brain with epilepsy protocols. Their antiepileptic drugs are discontinued during the hospitalization period in the EMU. Ten people (sham group) receive sham tDCS using the same position of the electrode. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is undecided
public Soheila Rezakhani Jafarabadi
Vice-challenger of Research, Ebn-e sina St., Jahad blvd.
Kerman Iran (Islamic Republic of) 7619813159 +98 34 3226 3855 drrezakhani@gmail.com Kerman University of Medical Sciences scientific Soheila Rezakhani Jafarabadi
Kerman Neuroscience Research Center, Ebn Sina st., Jehad Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) 7619813159 +98 34 3226 4196 drrezakhani@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with drug-resistant epilepsy as defined by the International League against epilepsy (ILAE) Over 18 years old In all patients, the probable epileptogenic zone is localized according to the epilepsy semiology and consecutive previous EEGs, and epileptogenic lesions are diagnosed by brain MRI with epilepsy protocol. 18 years no limit Both Under 18 years old generalized epilepsy scalp diseases such as eczema , cutaneous lesions , previous intracranial surgery previous intracranial surgery, intracranial metal (out of mouth) such as tracking, surgical clip implanted device such as cardiac pace maker, VNS, cochlear implant severe and recurrent headaches G40.21 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable Treatment - Devices Placebo Intervention group: Twenty patients diagnosed with drug-resistant epilepsy will be studied according to the definition of the International league against Epilepsy (ILAE) after approval by the Ethics and Signature of consent. In all patients with possible epileptogenic zone according to semiology. The patient's previous epilepsy and lumbar strips are localized, and epileptogenic lesions are diagnosed by MRI of the brain with epilepsy protocols. Their antiepileptic drugs are discontinued during hospitalization in the EMU. Participants are randomly assigned to the experimental or sham group. Ten participants (experimental group) performed HD a-tDCS intervention in a current of 2 mA to fashion. They receive 30 minutes on the second day of hospitalization in the EMU twice in 4 hours on the epileptogenic zone. Control group: Twenty patients diagnosed with drug-resistant epilepsy will be studied according to the definition of the International league against Epilepsy (ILAE) after approval by the Ethics and Signature of consent. In all patients with possible epileptogenic zone according to semiology. The patient's previous epilepsy and lumbar strips are localized, and epileptogenic lesions are diagnosed by MRI of the brain with epilepsy protocols. Their antiepileptic drugs are discontinued during the hospitalization period in the EMU. Ten people (sham group) receive sham tDCS using the same position of the electrode. Investigating changes in hospitalization duration in epilepsy monitoring unit. Timepoint: The frequency of epileptic seizures will be recorded in both groups for 7 days. Method of measurement: Record the number of attacks. Kerman University of Medical Sciences Approved 2020-01-27 Ethics committee of Kerman university of Medical Sciences Vice-challenger of Research, Ebn-e sina St., Jahad blvd. Kerman Kerman Iran (Islamic Republic of)