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IRCT20230731058985N1 IRCT 2023-08-11 Razi University Transcranial Pulsed current stimulation on Athletic and cognitive performance Investigating the effects of Transcranial Pulsed Current Stimulation on Athletic and Cognitive Performance in male trained cyclists 2023-09-22 anticipated 15 Complete https://irct.ir/trial/71730 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, the order of subject exposure to 3 different conditions (3 different types of electrical stimulation of the brain) will be randomized by Latin square method. For this purpose, first, using the www.random.org website, a number between 1 and 15 will be randomly assigned to each of the subjects as an identification code. Then, the English letters B, A and C will be assigned to the three intervention conditions and a Latin square will be created. In this case, a Latin square with three rows and three columns is created. Finally, participants number 1 to 5 are placed in the sequence of the first row, participants number 6 to 10 are placed in the sequence of the second row, and participants number 11 to 15 are placed in the sequence of the third row, Blinding description: In this double-blind study, the researcher and participants will be blinded to the type of transcranial electrical stimulation used and the location of stimulation in each session. In the present study, the Neurostim stimulation device was used to induce direct current electrical stimulation in three separate sessions and three different modes including: 1) Anodal stimulation of the primary motor cortex (M1), 2) Anodal stimulation of the dorsolateral prefrontal cortex (DLPFC) 3) sham stimulation (placebo) will be used. For this purpose, a person outside the research team will be responsible for applying electrical stimulation in three experimental sessions. In order to blind the participants, after they sit on a special chair, the electrical stimulation device of the brain is hidden from their sight and covered by a cover completely, and the electrodes will be placed on the desired areas by the examiner. In order to blind the researcher, before the intervention, the researcher leaves the laboratory and returns to the test site after the stimulation period has passed and the electrodes are removed and the stimulation device is turned off. Also, in the sham stimulation mode, according to standard protocols, the active current is induced on the head for 30 seconds to induce the same sensation as the active stimulation mode, and then the current is cut off and the stimulation is deactivated. N/A Participants are healthy and trained cyclists. Intervention 1: Intervention group: In this study, all subjects will be exposed to two intervention conditions with an interval of one week, including 1) anodal electrical brain stimulation of the primary motor cortex, 2) anodal electrical brain stimulation of the dorsolateral prefrontal cortex. In both conditions, the stimulation duration will be 20 minutes and its intensity will be 1/5 milliamperes. A Neurostim stimulator device made by Medina Teb Company will be used for brain stimulation. Target areas in the brain are identified using the International Brain Mapping 10-20 System. The stimulation of target areas is performed using two special electrodes and a special electroencephalogram (EEG) cap. Intervention 2: Control group: In this study, in addition to two intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying subjects. When: 6 months after printing the results To whom: researchers Conditions: For meta-analysis research Where to obtain: If you need to receive documents, send an email to hanie nozari, research researcher, with the email address: hana.nozari1997@gmail.com. How to obtain: In case of an official request, stating the relevant reasons and mentioning the complete details, the data will be sent via email after 72 hours. Comments:
public Vahid Tadibi
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 9265 vtadibi@yahoo.com Razi University scientific Vahid Tadibi
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 9265 vtadibi@yahoo.com Razi University Iran (Islamic Republic of) regular endurance cycling training in 6 months before the beginning of the research. The age range is 18 to 44 years Getting the certification of no prohibition of participating in the exercise training program from a medical doctor Male gender 18 years 44 years Male history of sports injury in the past month Suffering from any cardiovascular, pulmonary and metabolic diseases History of seizures, epilepsy, or other neurological diseases Existence of implantable devices or pacemakers in the body Tobacco and alcohol consumption Having color blindness Treatment - Devices Placebo Intervention group: In this study, all subjects will be exposed to two intervention conditions with an interval of one week, including 1) anodal electrical brain stimulation of the primary motor cortex, 2) anodal electrical brain stimulation of the dorsolateral prefrontal cortex. In both conditions, the stimulation duration will be 20 minutes and its intensity will be 1/5 milliamperes. A Neurostim stimulator device made by Medina Teb Company will be used for brain stimulation. Target areas in the brain are identified using the International Brain Mapping 10-20 System. The stimulation of target areas is performed using two special electrodes and a special electroencephalogram (EEG) cap. Control group: In this study, in addition to two intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes. Changes in endurance performance. Timepoint: During test execution. Method of measurement: Using endurance test. Amplitude of muscle electromyography. Timepoint: During endurance testing. Method of measurement: 16-channel wireless electromyography device (Noraxon model, Scottsdale, AZ85260). Rating of Perceived Exertion. Timepoint: During the execution of the endurance test and the time to reach the dead end. Method of measurement: By use of 6 to 20 perceived exertion Borg scale. Cognitive function. Timepoint: Before and after the application of stimulation and after the execution of the test. Method of measurement: by the use of Stroop Color-Word Test. Choice reaction time. Timepoint: Before and after the application of stimulation and after the execution of the test. Method of measurement: By the use of Response Panel (63035A, Lafayette, Indiana) reaction time device. Pleasure sensation. Timepoint: During the execution of the endurance test and the time to reach the dead end. Method of measurement: By the use of 11-item Feel Scale. Pain sensation. Timepoint: During the execution of the endurance test and the time to reach the dead end. Method of measurement: Using a scale of 0 to 10. Countdown cognitive test. Timepoint: During test execution. Method of measurement: Countdown to the distance of 3 numbers from the announced random number for one minute. The degree of arousal. Timepoint: During the execution of the endurance test and the time to reach the dead end. Method of measurement: By the use of 6-item Felt Arousal Scale. Razi University Approved 2023-05-03 Razi University Research Ethics Committee Iran, Kermanshah, Taq Bostan, University St., Razi University, Research Vice-Chancellor Kermanshah Kermanshah Iran (Islamic Republic of)