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IRCT20221016056187N1 IRCT 2022-11-19 Tehran University of Medical Sciences Comparison of effects of neurofeedback and transcranial electrical stimulation on motor learning in healthy subjects Comparison of short and long term effects of neurofeedback and transcranial electrical stimulation on the visuomotor skill learning in healthy subjects 2022-12-22 anticipated 100 Complete https://irct.ir/trial/66393 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants are assigned to 5 groups (real and sham transcranial electrical stimulation, real and sham neurofeedback, and control group) by the sequence created through the randomization.com site and by the balanced block randomization method. The size of the blocks is 10. Also, for the purpose of allocation concealment, sealed and numbered envelopes are used, which are provided to the participants by the secretary, Blinding description: The researcher who conducts interventions is different from the researcher who collects information and conducts statistical analysis.Therefore, the study is single-blind. N/A The effect of transcranial direct current stimulation and neurofeedback on motor learning. Intervention 1: Intervention group 1: transcranial direct current stimulation: To apply tdcs , the transcranial direct current device model neurostim 2 of Medina Tab Gostar Company is used. Before the participant arrives, all the tools, including electrodes, normal saline, stimulator, cable, elastic bands, and measuring tip, are checked to ensure that they are healthy and that there are no possible failures and damages. The participant sits in a chair, then the scalp is examined for any lesions. First, the electrodes are placed in a sponge soaked with normal saline and the skin of the stimulation site is cleaned with alcohol. The size of the electrodes is 5*4. An active electrode is placed on the primary motor area of ​​the dominant side, which corresponds to C3 or C4 according to the international 10-20 system. The cathode electrode is also placed on the supraorbital area of ​​the non-dominant hand. The electrodes are fixed on the head by two adhesive straps. A current with an intensity of 1 milliampere is applied for a period of 30 minutes with ram up for 30 seconds and ram down for 30 seconds. Intervention 2: Intervention group 2: sham transcranial direct current stimulation:In this group, all the conditions are the same as the real tdcs group. Only the current is cut off after 30 seconds of ramp up. Intervention 3: Intervention group 3: neurofeedback: Electroencephalography active electrodes are placed on the primary motor area of ​​the dominant side, the reference electrode is placed on the mastoid and the ground electrode is placed on the right arm. Filters are applied so that only the alpha wave is recorded. First, the alpha wave is recorded for three minutes with the eyes open in the primary motor area to determine the basic value of the alpha wave. Then, since the goal of neurofeedback is to increase the excitability of the brain by reducing the alpha wave in the primary motor area. The settings are made in such a way that in seventy percent of the time the threshold that causes the games to be played is below the basic threshold. The participants then train with neurofeedback for 30 minutes by sitting facing the monitor and watching the game being played.When the wave reaches below our desired value, the game will continue, and when the wave rises above our desired value, the game will be stopped. So, the brain will be directed to our desired direction (decrease the alpha wave) with the help of positive feedback (playing the game). 6 games will be played for 5 minutes each to prevent fatigue and reduce cooperation due to boredom. After training, electroencephalography is recorded for 3 minutes with eyes open. During the session, the researcher records the time of rapid head movements or sneezing and coughing of the participants to determine its effects in electroencephalography. Intervention 4: Intervention group 4: sham neurofeedback:The conditions are like real neurofeedback. 3 minutes of electroencephalography are recorded before and after the exercise, but during the exercise, a pre-recorded video of another participant is shown. Intervention 5: Control group: passive control: The passive control group does not receive any intervention and spends 30 minutes in the laboratory without physical and mental activity in addition to the normal state and then completes the SRTT task with the same time intervals as the intervention groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sara Rezaei eshkalak
Faculty of Rehabilitation ، Pich-e-Shemiran, Enghelab St
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 srh.rezaei@gmail.com Tehran University of Medical Sciences scientific Roya khanmohammadi
Faculty of Rehabilitation ، Pich-e-Shemiran, Enghelab St
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) healthy (both genders) 18-40 years old 18 years 40 years Both having a history of neurological diseases such as epilepsy and convulsions, concussion and migraine having an orthopedic or neurological or rheumatological injury that limits the upper limbs functions Cognitive and memory disorders (24 ≤ (Mini-Mental State Exam Uncorrected vision problems Taking drugs affecting the central nervous system The presence of mental illnesses such as anxiety and depression that are associated with drug use Intense physical activity 2 hours before the test A history of doing activities that require a lot of dexterity in the hands, such as playing the piano pregnancy sleep disorders Intracranial implants or cardiac pacemakers Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group 1: transcranial direct current stimulation: To apply tdcs , the transcranial direct current device model neurostim 2 of Medina Tab Gostar Company is used. Before the participant arrives, all the tools, including electrodes, normal saline, stimulator, cable, elastic bands, and measuring tip, are checked to ensure that they are healthy and that there are no possible failures and damages. The participant sits in a chair, then the scalp is examined for any lesions. First, the electrodes are placed in a sponge soaked with normal saline and the skin of the stimulation site is cleaned with alcohol. The size of the electrodes is 5*4. An active electrode is placed on the primary motor area of ​​the dominant side, which corresponds to C3 or C4 according to the international 10-20 system. The cathode electrode is also placed on the supraorbital area of ​​the non-dominant hand. The electrodes are fixed on the head by two adhesive straps. A current with an intensity of 1 milliampere is applied for a period of 30 minutes with ram up for 30 seconds and ram down for 30 seconds. Intervention group 2: sham transcranial direct current stimulation:In this group, all the conditions are the same as the real tdcs group. Only the current is cut off after 30 seconds of ramp up. Intervention group 3: neurofeedback: Electroencephalography active electrodes are placed on the primary motor area of ​​the dominant side, the reference electrode is placed on the mastoid and the ground electrode is placed on the right arm. Filters are applied so that only the alpha wave is recorded. First, the alpha wave is recorded for three minutes with the eyes open in the primary motor area to determine the basic value of the alpha wave. Then, since the goal of neurofeedback is to increase the excitability of the brain by reducing the alpha wave in the primary motor area. The settings are made in such a way that in seventy percent of the time the threshold that causes the games to be played is below the basic threshold. The participants then train with neurofeedback for 30 minutes by sitting facing the monitor and watching the game being played.When the wave reaches below our desired value, the game will continue, and when the wave rises above our desired value, the game will be stopped. So, the brain will be directed to our desired direction (decrease the alpha wave) with the help of positive feedback (playing the game). 6 games will be played for 5 minutes each to prevent fatigue and reduce cooperation due to boredom. After training, electroencephalography is recorded for 3 minutes with eyes open. During the session, the researcher records the time of rapid head movements or sneezing and coughing of the participants to determine its effects in electroencephalography. Intervention group 4: sham neurofeedback:The conditions are like real neurofeedback. 3 minutes of electroencephalography are recorded before and after the exercise, but during the exercise, a pre-recorded video of another participant is shown. Control group: passive control: The passive control group does not receive any intervention and spends 30 minutes in the laboratory without physical and mental activity in addition to the normal state and then completes the SRTT task with the same time intervals as the intervention groups. Normalized reaction time. Timepoint: Before intervention/after training/35 minutes after training/48 hours after training. Method of measurement: Serial Reaction Time Task software. The number of normalized errors. Timepoint: Before intervention/after training/35 minutes after training/48 hours after training. Method of measurement: Serial Reaction Time Task software. Hand fatigue. Timepoint: Beginning of the first session/End of the first session. Method of measurement: Visual Analogue Scale (VAS). Level of mental fatigue. Timepoint: Beginning of the first session/End of the first session. Method of measurement: Visual Analogue Scale (VAS). Tehran University of Medical Sciences Approved 2022-10-25 Ethics Committee in Research Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran Faculty of Rehabilitation of Tehran ofuniversity Medical sciences، Pich-e-Shemiran, Enghelab St,District 12 Tehran Tehran Iran (Islamic Republic of)