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IRCT20130812014333N162 IRCT 2021-03-17 Kermanshah University of Medical Sciences The effects of stimulation of transcranial direct current in nocturnal sleep on in the mild cognitive impairment patients Study the effects of stimulation of transcranial direct current in nocturnal sleep on the Glymphatic system in the mild cognitive impairment patients: A randomized controlled parallel clinical trial 2021-04-04 anticipated 24 Complete https://irct.ir/trial/54680 interventional Randomization: Randomized, Blinding: Single 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, 8 blocks with random permutations and in each block, 3 samples with one of the 6 possible permutations will be assigned to three groups, which in total 24 samples with the same volume will be assigned to three groups, Blinding description: In this single-blinded study, patients are unaware that they will be assigned to the first, second, or control group. 2-3 Mild cognitive disorder. Intervention 1: The first intervention group will receive an active transcranial direct current stimulation (TDCS) overnight. Stimulation begins anodally at a frequency of 0.75 Hz, 4 minutes after individuals enter the second phase of nonREM sleep for the first time. A total of 5 5-minute stimuli applied at 1-minute intervals are applied. Intervention 2: The second intervention group will receive active transcranial direct current stimulation (TDCS) for two consecutive nights. Stimulation begins anodally at a frequency of 0.75 Hz, 4 minutes after individuals enter the second phase of nonREM sleep for the first time. A total of 5 5-minute stimuli applied at 1-minute intervals are applied. Intervention 3: The control group is stimulated with sham (in which the electrodes of the TDCS device are connected according to the protocol but the device is off). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Fatemeh Haj Zeinolabedini
School of Medicine, parastar boulvarde
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 hanie.zeinolabedini@gmail.com Kermanshah 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) Age over 55 years Diagnosis of mild cognitive impairment based on Petersen 2004 clinical criteria The score of mental state short test between 24 and 30, and CDR equal to 0.5 55 years no limit Both History of central nerve diseases (such as stroke, tumor and brain trauma, epilepsy, psychiatric illness, etc.) The presence of metal parts in the brain, skull and anywhere else in the body Alcohol and drug addiction Use of drugs affecting the central nervous system and sleep disorders F06.7 Mild cognitive disorder Treatment - Other Treatment - Other Other The first intervention group will receive an active transcranial direct current stimulation (TDCS) overnight. Stimulation begins anodally at a frequency of 0.75 Hz, 4 minutes after individuals enter the second phase of nonREM sleep for the first time. A total of 5 5-minute stimuli applied at 1-minute intervals are applied. The second intervention group will receive active transcranial direct current stimulation (TDCS) for two consecutive nights. Stimulation begins anodally at a frequency of 0.75 Hz, 4 minutes after individuals enter the second phase of nonREM sleep for the first time. A total of 5 5-minute stimuli applied at 1-minute intervals are applied. The control group is stimulated with sham (in which the electrodes of the TDCS device are connected according to the protocol but the device is off). The rate of activity of the glymphatic system. Timepoint: Before and after interventions (30 minutes after the start of the intervention). Method of measurement: Using Tensor Diffusion Imaging (DTI). Kermanshah University of Medical Sciences Approved 2021-01-12 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)