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IRCT20190522043673N2 IRCT 2021-03-02 Guilan University of Medical Sciences The effect of tDCS on memory in mild cognitive impairment patients The effect of bihemispheric transcranial direct current stimulation on memory abilities and parameters of quantitative electroencephalography (qEEG) in mild cognitive impairment patients 2021-05-21 anticipated 36 Complete https://irct.ir/trial/54452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used; with a block size of 4; Allocation concealment will be performed using sealed envelope software. The participants will be allocated to group A or B, using blocked randomization (Block size: 4). One of the groups receive active tDCS, while the other is sham stimulated, neither the participants nor the allocator is not aware that which group will be the treatment group. The physiotherapist, applying the tDCS, is the only researcher who knows the treatment and the sham group. After treatment (or sham stimulation), the data will be analyzed by the statistician, who is either blind to the data groups, Blinding description: The participants will be allocated to group A or B, using blocked randomization. Neither the participants nor the allocator is not aware that which group will be the treatment group. The physiotherapist, applying the tDCS, is the only researcher who knows the treatment and the sham group. After treatment (or sham stimulation), the data will be analyzed by the statistician, who is also blind to the treatment/sham groups. 2-3 Mild cognitive impairment. Intervention 1: Active tDCS group; the anodal electrode will be placed on the left dorsolateral prefrontal cortex (DLPFC), which is equivalent to F3 zone according to the standard 10-20 electrode placement system. The cathodal electrode will be placed on the opposite side (F4 zone). Stimulation with a current intensity of 2 mA will be applied for 30 min for ten consecutive sessions. Intervention 2: Sham tDCS; Both electrodes will be placed as in active group. Current will be applied for 30 seconds (10 seconds ramp-up, 10 seconds 2 mA and 10 seconds ramp-down). The electrodes remain in place for 30 minutes but no current will be applied to assess the placebo effect of the intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Kambiz Rohampour
Guilan University Complex, 6th km of Tehran road,
Rasht Iran (Islamic Republic of) 4193853948 +98 13 3369 0884 rohampour@gmail.com Guilan University of Medical Sciences scientific Alia Saberi
Namjou street, Poursina Hospital
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3369 0884 Alia.saberi.1@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of mild cognitive impairment (MCI) performed by a neurologist based on criteria revised by the National Institute on Aging and Alzheimer's (NIA-AA) in 2012. MMSE score between 19 - 24 age of 50 to 80 years Literacy in Persian Being right-handed 50 years 80 years Both History of dementia or mental retardation Consumption of cognitive enhancers Reversible medical conditions associated with potential cognitive impairment Recent diagnosis of alcoholism or alcohol-based disorders based on the DSM-V Epilepsy Severe clinical conditions include cardiovascular, gastrointestinal, respiratory, endocrine, and CNS diseases History of cerebrovascular surgery Patients who have participated in another clinical study in the last 30 days Contraindications to brain stimulation with tDCS G31.84 Mild cognitive impairment, so stated Treatment - Devices Placebo Active tDCS group; the anodal electrode will be placed on the left dorsolateral prefrontal cortex (DLPFC), which is equivalent to F3 zone according to the standard 10-20 electrode placement system. The cathodal electrode will be placed on the opposite side (F4 zone). Stimulation with a current intensity of 2 mA will be applied for 30 min for ten consecutive sessions. Sham tDCS; Both electrodes will be placed as in active group. Current will be applied for 30 seconds (10 seconds ramp-up, 10 seconds 2 mA and 10 seconds ramp-down). The electrodes remain in place for 30 minutes but no current will be applied to assess the placebo effect of the intervention. Wechsler Memory Scale (WMS). Timepoint: Before intervention - After intervention - 3 month after intervention. Method of measurement: Wechsler Memory Scale (WMS) questionnaire. Absolute power in different band frequencies in EEG. Timepoint: Before intervention - immediately after intervention - 3 month after intervention. Method of measurement: EEG recording and qEEG analysis with Matlab software. Guilan University of Medical Sciences Approved 2021-02-17 Ethics committee of Guilan University of Medical Sciences Poursina Hospital, Namjou street, Emam blvd. Rasht Guilan Iran (Islamic Republic of)