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IRCT20220724055538N1 IRCT 2022-08-04 Razi university Non-invasive brain stimulation and endurance performance Investigating the effect of Transcranial Direct Current Stimulation on Endurance and Cognitive Performance of Trained Men with and without Mental Fatigue 2022-08-23 anticipated 16 Complete https://irct.ir/trial/64910 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, the order of subject exposure to 4 different conditions (4 different types of electrical stimulation of the brain) will be randomized by the Latin square method. For this purpose, a number between 1 and 16 will be randomly assigned to each of the subjects as an identification code using www.random.org. Then, the English letters B, A, C, and D will be assigned to the four intervention conditions and a Latin square will be created. In this case, a Latin square with four rows and four columns is created. Finally, participants number 1 to 4 are placed in the sequence of the first row, participants number 5 to 8 are placed in the sequence of the second row, participants number 8 to 12 are placed in the sequence of the third row, and participants 13 to 16 are placed in the sequence of the fourth 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 current study, the neurostimulator device was used to induce direct current electrical stimulation in four separate sessions and four different modes, including: 1) induction of mental fatigue + brain anodal stimulation + running until reaching paralysis; 2) induction of mental fatigue + sham stimulation + running until reaching exhaustion; 3) cerebral anodal stimulation + running until exhaustion (without inducing mental fatigue); 4) Stimulation + running will be until reaching exhaustion (without inducing mental fatigue). For this purpose, a person outside the research team will be responsible for applying electrical stimulation in four experimental sessions. In order to blind the participants, after they sit on a special chair, the stimulating device is hidden from their sight and is completely covered by a cover, and the electrodes are 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 The participants are healthy people.. Intervention 1: Intervention group: 1) induction of mental fatigue + brain anodal stimulation + running until reaching paralysis; 2) induction of mental fatigue + sham stimulation + running until reaching exhaustion; 3) cerebral anodal stimulation + running until exhaustion (without inducing mental fatigue); 4) Stimulation + running will be until reaching exhaustion (without inducing mental fatigue). Intervention 2: Control group: In this research, in addition to three intervention sessions, all subjects are exposed to one control session including electrical stimulation of the brain in a sham state (placebo effect). All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, the electrical stimulation of the brain is not done and the electrical current of the stimulating device will be deactivated after 30 seconds. The duration of the control condition will 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: 3 months after printing the results To whom: All people upon official request Conditions: Requesting access to data for any purpose is permitted Where to obtain: If you need to receive the documents, send an email to Armin Amiryan, the researcher, with the email address: arminamiriyan76@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 Armin Amirian
unit 1, next to the cooperative office, rural, second station, Farhangian phase 2, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6715773159 +98 83 3423 9003 arminamiriyan76@gmail.com Razi University of Kermanshah scientific Armin Amirian
unit 1, next to the cooperative office, rural, second station, Farhangian phase 2, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6715773159 +98 83 3423 9003 arminamiriyan76@gmail.com Razi uinversity of Kermanshah Iran (Islamic Republic of) Endurance training men with at least one year of regular training Body mass index (BMI) 18.5 to 24.9 kg/m2 Obtaining a certificate of non-prohibition of participating in sports training programs from a doctor Being right-handed Absence of color blindness or color vision disorders Age range from 18 to 30 years 18 years 30 years Male Suffering from any chronic disease History of seizures, epilepsy or other types of neurological diseases Presence of implantable devices or pacemakers in the body Smoking and alcohol consumption Treatment - Devices Placebo Intervention group: 1) induction of mental fatigue + brain anodal stimulation + running until reaching paralysis; 2) induction of mental fatigue + sham stimulation + running until reaching exhaustion; 3) cerebral anodal stimulation + running until exhaustion (without inducing mental fatigue); 4) Stimulation + running will be until reaching exhaustion (without inducing mental fatigue). Control group: In this research, in addition to three intervention sessions, all subjects are exposed to one control session including electrical stimulation of the brain in a sham state (placebo effect). All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, the electrical stimulation of the brain is not done and the electrical current of the stimulating device will be deactivated after 30 seconds. The duration of the control condition will be 20 minutes. Changes in endurance performance. Timepoint: After endurance activity. Method of measurement: Laboratory treadmill (CosMed, T300, Italy). Amplitude of muscle electromyography. Timepoint: Every five minutes for 30 seconds. Method of measurement: 16-channel wireless electromyography device (Noraxon model, Scottsdale, AZ85260). The degree of perception of pressure. Timepoint: Every three minutes. Method of measurement: Using a pressure perception scale of 6 to 20 borg. Cognitive function. Timepoint: Before and after maximal aerobic test. Method of measurement: Using the color-word Stroop test. Selective reaction time. Timepoint: Before and after endurance activity. Method of measurement: Using the response time device of Response Panel (63035A, Lafayette, Indiana). Sense of pleasure. Timepoint: Every three minutes. Method of measurement: Using an 11-item emotion scale. Arousal level. Timepoint: Every three minutes. Method of measurement: Using a 6-item scale of perceived arousal. Razi university Approved 2022-07-06 Ethics Committee of Razi University unit 1, next to the cooperative office, rural, second station, Farhangian phase 2, Kermanshah, Iran kermanshah Kermanshah Iran (Islamic Republic of)