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IRCT2012071310267N1 IRCT 2012-09-16 Vice chancellor for research, Tehran University of Medical Science Evaluating Direct Current Stimulation effect on memory performance Evaluating the effect of anodal transcranial Direct Current Stimulation on working memory performance in individuals with Mild Cognitive Impairment 2012-10-22 anticipated 20 Complete https://irct.ir/trial/10731 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: Randomization: Subjects assigned to different strata according to their education level. In each stratum, we use blocks with different size in order to prevent selection bias and the allocation ratio is 1:1. (Stratified block randomization) Blinding: The person who implements the randomization and enrolls participants is blinded during allocation. All participants are also blinded about their final group. All data will be analyzed by a blind analyzer, who does not know which participant allocated to which group. Trial design: Because in cross over trials, the therapeutic effects of two different modes of intervention (active tDCS versus sham tDCS) will be compared in each person with same characteristics, which is better than this comparison in two different persons with different characteristics, in this Randomized Controlled Clinical Trial, cross over design is chosen. Therefore, effects of confounding variables will be minimized and fewer biases will threaten study results. 2-3 Mild cognitive disorder. Intervention 1: Intervention Group: Transcranial Direct Current Stimulation is a non-invasive and non-convulsive technique with high safety rate and low side-effect incidence. It can modulate cortical excitability in target region of the brain, so that anodal and cathodal tDCS would increase and decrease cortical excitability, respectively. According to “10-20 international system for EEG electrode placement” the anode will be placed on F3 (left DLPFC) , while the cathode would be locate on contralateral (right) supraorbital region. Electrodes (35cm2) will be inserted in saline soaked sponges. These sponges will be washed from participant to participant, to avoid further saline concentrating. Each person in case group receives 1 mA current for 20 minutes. Intervention 2: Control Group: Electrodes will be fixed on subject's head for 20 minutes. In sham group, the current reach the maximum dose (1mA) gradually, then cut off. This help participants feel the initial tingling and so remain blind during previously mentioned 20 minutes.
public Dr. Masoud Mehrpour
Firoozgar Hospital, Beh Afarin Street, Karimkhan zand Street, Tehran
Tehran Iran (Islamic Republic of) +98 21 8214 1600 m-mehrpour@tums.ac.ir; fgowhari@gmail.com Firoozgar Hospital, Tehran University of Medical Science scientific Dr. Masoud Mehrpour
Firoozgar Hospital, Beh Afarin Street, Karimkhan zand Street, Tehran
Tehran Iran (Islamic Republic of) +98 21 8214 1600 m-mehrpour@tums.ac.ir; fgowhari@gmail.com Firoozgar Clinical Research Development Center, Tehran University of Medical Science Iran (Islamic Republic of) Inclusion criteria: Twenty volunteers with diagnosed MCI according to Peterson’s criteria will be recruited. None of them must have any neurological, physical, or other life threatening disease. All the subjects are right-handed and non-pregnant. Exclusion criteria: Lost to follow up 30 years 80 years Both F06.7 Mild cognitive disorder Treatment - Devices Treatment - Devices Intervention Group: Transcranial Direct Current Stimulation is a non-invasive and non-convulsive technique with high safety rate and low side-effect incidence. It can modulate cortical excitability in target region of the brain, so that anodal and cathodal tDCS would increase and decrease cortical excitability, respectively. According to “10-20 international system for EEG electrode placement” the anode will be placed on F3 (left DLPFC) , while the cathode would be locate on contralateral (right) supraorbital region. Electrodes (35cm2) will be inserted in saline soaked sponges. These sponges will be washed from participant to participant, to avoid further saline concentrating. Each person in case group receives 1 mA current for 20 minutes. Control Group: Electrodes will be fixed on subject's head for 20 minutes. In sham group, the current reach the maximum dose (1mA) gradually, then cut off. This help participants feel the initial tingling and so remain blind during previously mentioned 20 minutes. Spatial Working Memory Score. Timepoint: at the beginning before the intervention, immediately after the first intervention session, immediately after the second intervention session. Method of measurement: CANTAB, executive function package, spatial working memory test. Mental State. Timepoint: at the beginning before the intervention. Method of measurement: Mini Mental State Examination (MMSE). Dementia rating. Timepoint: at the beginning before the intervention. Method of measurement: Clinical Dementia Rating (CDR) score. Vice chancellor for research, Tehran University of Medical Science Approved 2012-07-02 Tehran University of Medical Science Ethic Committee Medical Ethic Resaerch Center, Tehran University of Medical Science, 16th Azar Street, Keshavarz Blvd., Tehran Tehran Iran (Islamic Republic of)