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IRCT20200111046082N1 IRCT 2020-04-03 Kerman University of Medical Sciences The assessment efficacy of electrical brain stimulation among patients with drug-resistant epilepsy The Efficacy assessment of high definition cathodal transcranial direct current stimulation in treatment of patients with drug-resistant epilepsy 2018-05-05 anticipated 22 Complete https://irct.ir/trial/45477 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients randomly divided in two groups (20 patients in each group) using random allocation sequence with SAS statistical software. according to this method a simple randomization list product and patients`involvement in each group determine base on order entry. we used sequentially numbered, sealed opaque envelopes for allocation concealment. patients (individuals) were the randomization units, 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:Patients with drug-resistant epilepsy who are not good candidates for epilepsy surgery or who do not want surgery or are waiting for surgery. In all patients, the epileptogenic zone is localized during prolonged EEG video-EEG monitoring, and epileptogenic lesions are diagnosed by brain epilepsy with epilepsy protocol. Their antiepileptic drugs did not change during the study period. Participants are randomly assigned to an experimental or sham group. Ten participants (experimental group) received HD c-tDCS intervention in a 2 mA current for 30 minutes for 10 consecutive days over the epileptogenic zone. The standard 30-min brain tape will be administered in two groups immediately before and after the first and monthly stimulation for three months. Patients will also be tracked by the cigarette calendar. The frequencies of the intraectal epiglottis signals and waves before and after HD C-TDCS will be compared statistically. Quality of life (QoL) of patients will be assessed by QoL-Epilepsy Questionnaire -89 before the intervention and after three months. After each session of stimulation, side effects will be questioned and recorded. Intervention 2: Control group: Patients with drug-resistant epilepsy who are not good candidates for epilepsy surgery or who do not want surgery or are waiting for surgery. In all patients, the epileptogenic zone is localized during prolonged EEG video-EEG monitoring, and epileptogenic lesions are diagnosed by brain epilepsy with epilepsy protocol. Their antiepileptic drugs did not change during the study period. Participants were randomly assigned to the experimental or sham group. In ten patients for sham stimulation, the electrodes were placed in exactly the same position as the active stimulation on the scalp and the patient received stimulation for only 60 seconds. The remaining 30 minutes remain in place. The flow increases slowly in the first 15 seconds and decreases slowly in the last 15 seconds. Patients develop a sense of pruritus and murmur, but receive no flow for the remaining 29 minutes. 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
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
Krman 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) age>=18 y/o all of patients full filled ILAE criteria of drug-resistant epilepsy participants were not good candidate for epilepsy surgery and or they will not surgery or they waited for epilepsy surgery. obtaining signed consent 18 years no limit Both scalp diseases(such as eczema, skin lesions) previous intracranial surgery, intracranial metal (out of mouth) such as cracking, surgical clip implanted device such as cardiac pacemaker, VNS, Cochlear implantation recurrent or severe headaches previous head trauma and other related brain diseases pregnancy and lactation G40.21 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable Treatment - Devices Placebo Intervention group:Patients with drug-resistant epilepsy who are not good candidates for epilepsy surgery or who do not want surgery or are waiting for surgery. In all patients, the epileptogenic zone is localized during prolonged EEG video-EEG monitoring, and epileptogenic lesions are diagnosed by brain epilepsy with epilepsy protocol. Their antiepileptic drugs did not change during the study period. Participants are randomly assigned to an experimental or sham group. Ten participants (experimental group) received HD c-tDCS intervention in a 2 mA current for 30 minutes for 10 consecutive days over the epileptogenic zone. The standard 30-min brain tape will be administered in two groups immediately before and after the first and monthly stimulation for three months. Patients will also be tracked by the cigarette calendar. The frequencies of the intraectal epiglottis signals and waves before and after HD C-TDCS will be compared statistically. Quality of life (QoL) of patients will be assessed by QoL-Epilepsy Questionnaire -89 before the intervention and after three months. After each session of stimulation, side effects will be questioned and recorded. Control group: Patients with drug-resistant epilepsy who are not good candidates for epilepsy surgery or who do not want surgery or are waiting for surgery. In all patients, the epileptogenic zone is localized during prolonged EEG video-EEG monitoring, and epileptogenic lesions are diagnosed by brain epilepsy with epilepsy protocol. Their antiepileptic drugs did not change during the study period. Participants were randomly assigned to the experimental or sham group. In ten patients for sham stimulation, the electrodes were placed in exactly the same position as the active stimulation on the scalp and the patient received stimulation for only 60 seconds. The remaining 30 minutes remain in place. The flow increases slowly in the first 15 seconds and decreases slowly in the last 15 seconds. Patients develop a sense of pruritus and murmur, but receive no flow for the remaining 29 minutes. Investigating changes in the frequency of epileptic seizures. Timepoint: before intervention and monthly for 3 months. Method of measurement: seizure diary. Investigating the frequency changes of interictal epileptiform discharges. Timepoint: immediately before and after intervention and then monthly for 3 months. Method of measurement: 30 minutes standard EEG. Side effects. Timepoint: immediately after stimulation. Method of measurement: specialist visit. Quality of life. Timepoint: before intervention and after 3 months. Method of measurement: full filling of the QoL in Epilepsy Inventory-89. Kerman University of Medical Sciences Approved 2018-08-13 Ethics committee of Kerman university of Medical Sciences Vice-challenger of Research, Ebn-e sina St., Jahad blvd. Kerman Kerman Iran (Islamic Republic of)