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IRCT20130812014333N163 IRCT 2021-03-21 Kermanshah University of Medical Sciences The Efficacy of transcranial direct current stimulation in treatment of patients with Mild Cognitive Impairment (MCI) The Efficacy of High Definition anodal transcranial direct current stimulation in treatment of patients with Mild Cognitive Impairment (MCI), A Randomized, double-blind, parallel-controlled clinical trial 2021-04-09 anticipated 90 Complete https://irct.ir/trial/54747 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random blocks. First, the size of each block is determined by 3, then all the triple permutations (for three interventions, for example, A, B, C) are determined. In this step we will have 6 possible permutations (ABC / ACB / BAC / BCA / CBA / CAB) for each block. Finally, 30 blocks with random permutations and in each block, 3 samples with one of the 6 possible permutations will be assigned to three intervention, that in total 90 samples with the same volume will be assigned to three groups. It should be noted that random numbers will be used to assign each permutation in each block, Blinding description: In this double-blind study, patients and researchers are unaware of the coding of intervention groups and TDCS stimulation will be performed by a clinical caregiver. N/A Mild cognitive disorder. Intervention 1: In the first intervention group, anodic TDCS stimulation is performed on the left prefrontal dorsolateral cortex with a current of 2 mA for 20 minutes 5 days a week, for two weeks. Intervention 2: In the second intervention group, anodic TDCS stimulation will be performed on the anterior temporal cortex with a current of 2 mA for 20 minutes, 5 days a week, for two weeks. Intervention 3: The third group will receive Sham stimulation for only 60 seconds (5 days a week, for two weeks) but the electrodes will remain in their place for 20 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Soheila Rezakhani
Kerman Neuroscience Research Center, Tahmasbabad intersection in front of Besat Clinic
Kerman Iran (Islamic Republic of) 3432264180 +98 34 3226 4196 drrezakhani@gmail.com Kerman University of Medical Sciences scientific Dr. Mahmoud Amiri
Medical Biology Research Center, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6714415185 +98 83 3427 6473 ma_amiri_bme@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of mild cognitive impairment Education level 4 or more The duration of symptoms of mild cognitive impairment is at least one year 55 years 90 years Both Epilepsy; Taking any medication that affects the central nervous system Focal neurological defects in neurological examination Scalp diseases Previous intracranial surgery, metal inside the head (outside the mouth) such as shrapnel, surgical clips History of recurrent or severe headaches F06.7 Mild cognitive disorder Other Other Other In the first intervention group, anodic TDCS stimulation is performed on the left prefrontal dorsolateral cortex with a current of 2 mA for 20 minutes 5 days a week, for two weeks. In the second intervention group, anodic TDCS stimulation will be performed on the anterior temporal cortex with a current of 2 mA for 20 minutes, 5 days a week, for two weeks. The third group will receive Sham stimulation for only 60 seconds (5 days a week, for two weeks) but the electrodes will remain in their place for 20 minutes. Quality of Life. Timepoint: Before the intervention and three months after the end of the intervention. Method of measurement: Using a quality of life questionnaire. Cognitive status. Timepoint: Before stimulation, after the second week, one and three months after the end of the study. Method of measurement: Using the Montreal Cognitive Test (MoCA). Kermanshah University of Medical Sciences Approved 2021-02-11 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)