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IRCT20221023056277N2 IRCT 2023-02-24 Semnan University of Medical Sciences The comparative effect of anodal and cathodal electrical brain stimulation of the motor area of the brain with different intensity of currents on motor learning of healthy young people Comparative effect of anodal and cathodal transcranial direct current stimulation (tDCS) over the motor cortex with different stimulation intensity on motor learning in healthy young adults 2023-04-02 anticipated 100 Complete https://irct.ir/trial/68511 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Numbers 1 to 100 are written on paper and all of them are placed in closed envelopes. Then the patients are asked to choose one envelope each. Patients whose envelope numbers are 1-20 in intervention group 1, 40-21 in intervention group 2, 41-60 in intervention group 3, 61-80 in intervention group 4, and patients whose envelope numbers are 81-100 in the control group will be placed, Blinding description: This study is double blind. Outcome assessor and analyzer and participant will be blind (double blind) and will not be aware from grouping. Definition of groups A, B and C will be available to analyzer and outcome assessor. N/A Investigating the comparative effect of anodal and cathodal electrical brain stimulation of the motor area of the brain with different current intensities on the motor learning of healthy young people. Intervention 1: first intervention group: To use the TDCS tool in the intervention groups, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulating electrodes are 5x7 cm in size and are made of sponge soaked in saltwater solution. When using TDCS, a current of 1 mA is applied to the skull for a maximum of 20 minutes. Electrical brain stimulation will be used for 20 minutes at the same time as SRTT cognitive motor task. In two anodal groups, in order to stimulate the motor area of the brain using anodal tDCS, the anode active electrode is placed on the left motor area of the brain (C3) and the cathode electrode is placed on the right side of the frontal area. Electrical stimulation with an intensity of 1 mA and with a gradual slope is applied for 20 minutes. Intervention 2: second intervention group: To use the TDCS tool in the intervention groups, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulating electrodes are 5x7 cm in size and are made of sponge soaked in saltwater solution. When using TDCS, a current of 2 mA is applied to the skull for a maximum of 20 minutes. Electrical brain stimulation will be used for 20 minutes at the same time as SRTT cognitive motor task. In two anodal groups, in order to stimulate the motor area of the brain using anodal tDCS, the anode active electrode is placed on the left motor area of the brain (C3) and the cathode electrode is placed on the right side of the frontal area. Electrical stimulation with an intensity of 2 mA and with a gradual slope is applied for 20 minutes. Intervention 3: third intervention group: When using TDCS cathodal on the motor area of the brain, in the cathodal group, the cathode active electrode is placed on the motor area on the left side of the brain (C3) and the anode electrode is placed on the right side of the forehead area. In the group, a cathodal with an intensity of 1 milliampere is placed. It is applied with a gradual gradient for 20 minutes. Intervention 4: fourth intervention group: When using TDCS cathodal on the motor area of the brain, in the cathodal group, the cathode active electrode is placed on the motor area on the left side of the brain (C3) and the anode electrode is placed on the right side of the forehead area. In the group, a cathodal with an intensity of 2 milliampere is placed. It is applied with a gradual gradient for 20 minutes. Intervention 5: Control group: In the Sham tDCS group, the anode and cathode electrodes will be selected randomly, and like the previous groups, the active electrode will be placed in the motor area of the brain and the inactive electrode will be placed on the right frontal area. The current will increase up to the first 45 seconds, and then it will reach zero again in 60 seconds, and like the previous groups, the electrodes will remain without current on the respective areas for up to 20 minutes. The motor serial task test for the people of all five groups within 72 hours after The test of the first session will be repeated again. Electrical stimulation of the brain will not be used in this session. Finally, the reaction time and the number of errors regarding the task sequences will be recorded and analyzed before using the main test and during two intervention sessions. No - There is not a plan to make this available Justification or reason for not sharing IPD is No - there are no plans to publish it
public Fatemeh Ehsani
Semnan, Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3365 4180 fatemehehsani59@yahoo.com Semnan University of Medical Sciences scientific Fatemeh Ehsani
Semnan, Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3365 4180 fatemehehsani59@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Young people with an age range of 18-35 years The dominant hand of people should be the right hand 18 years 35 years Both Report any history of neurological diseases such as Parkinson's, Alzheimer's, schizophrenia and dyslexia, so that the disease affects people's ability to learn. Report any history of psychological diseases Report of exposure to currents affecting the central nervous system during the last two weeks Report the use of any sedative drugs in the past two days Report any symptoms of forgetfulness and depression Memory disorders with a score less than 21 through the MMSE test The presence of any symptoms of movement disorders in the upper limb of the right hand, which, based on the researcher's assessment and diagnosis, causes movement restriction in the joints of the upper limb. The presence of any symptoms of radiculopathy, carpal tunnel syndrome in the right hand as diagnosed by the researcher Report uncorrected vision and hearing impairments Report dizziness Users of pacemaker Diagnosis Diagnosis Diagnosis Diagnosis Placebo first intervention group: To use the TDCS tool in the intervention groups, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulating electrodes are 5x7 cm in size and are made of sponge soaked in saltwater solution. When using TDCS, a current of 1 mA is applied to the skull for a maximum of 20 minutes. Electrical brain stimulation will be used for 20 minutes at the same time as SRTT cognitive motor task. In two anodal groups, in order to stimulate the motor area of the brain using anodal tDCS, the anode active electrode is placed on the left motor area of the brain (C3) and the cathode electrode is placed on the right side of the frontal area. Electrical stimulation with an intensity of 1 mA and with a gradual slope is applied for 20 minutes. second intervention group: To use the TDCS tool in the intervention groups, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulating electrodes are 5x7 cm in size and are made of sponge soaked in saltwater solution. When using TDCS, a current of 2 mA is applied to the skull for a maximum of 20 minutes. Electrical brain stimulation will be used for 20 minutes at the same time as SRTT cognitive motor task. In two anodal groups, in order to stimulate the motor area of the brain using anodal tDCS, the anode active electrode is placed on the left motor area of the brain (C3) and the cathode electrode is placed on the right side of the frontal area. Electrical stimulation with an intensity of 2 mA and with a gradual slope is applied for 20 minutes. third intervention group: When using TDCS cathodal on the motor area of the brain, in the cathodal group, the cathode active electrode is placed on the motor area on the left side of the brain (C3) and the anode electrode is placed on the right side of the forehead area. In the group, a cathodal with an intensity of 1 milliampere is placed. It is applied with a gradual gradient for 20 minutes fourth intervention group: When using TDCS cathodal on the motor area of the brain, in the cathodal group, the cathode active electrode is placed on the motor area on the left side of the brain (C3) and the anode electrode is placed on the right side of the forehead area. In the group, a cathodal with an intensity of 2 milliampere is placed. It is applied with a gradual gradient for 20 minutes Control group: In the Sham tDCS group, the anode and cathode electrodes will be selected randomly, and like the previous groups, the active electrode will be placed in the motor area of the brain and the inactive electrode will be placed on the right frontal area. The current will increase up to the first 45 seconds, and then it will reach zero again in 60 seconds, and like the previous groups, the electrodes will remain without current on the respective areas for up to 20 minutes. The motor serial task test for the people of all five groups within 72 hours after The test of the first session will be repeated again. Electrical stimulation of the brain will not be used in this session. Finally, the reaction time and the number of errors regarding the task sequences will be recorded and analyzed before using the main test and during two intervention sessions. One block time (SRT). Timepoint: The reaction time of performing each sequence in all five groups is measured and recorded before applying the current, 35 minutes after TDCS and 72 hours after applying this current. Method of measurement: The time of one block (SRT) is measured with CMT software. Number of errors. Timepoint: The number of errors in people of all five groups is measured and recorded before applying the current, 35 minutes after TDCS and 72 hours after applying this current. Method of measurement: The number of errors is measured by CMT software. Semnan University of Medical Sciences Approved 2023-02-07 Ethics Committee of Semnan University of Medical Sciences Basij Blvd., Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)