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IRCT20250812066842N1 IRCT 2025-08-16 Razi University Non-invasive brain stimulation and Endurance function Comparing the Effects of Transcranial Direct and Pulsed Current Stimulation on Endurance and Cognitive Performance in Physical Education Students 2025-09-23 anticipated 15 Complete https://irct.ir/trial/85516 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: To randomize the order in which participants are exposed to the three conditions in this study, a Latin square design will be employed. For this purpose, each participant will first be assigned a unique identification number between 1 and 15 using the website www.random.org. Next, the letters B, A, and C will be assigned to the three intervention conditions, and a Latin square will be constructed. In this configuration, a Latin square with three rows and three columns will be created. Finally, participants numbered 1 to 5 will follow the sequence in the first row, participants numbered 6 to 10 will follow the sequence in the second row, and participants numbered 11 to 15 will follow the sequence in the third row, Blinding description: Both the participants and the principal investigator will be blinded to the type of stimulation received in each session. This information will remain accessible only to an individual outside the research team until the completion of the study. To maintain blinding of the stimulation order from the principal investigator, all procedures related to the random assignment of stimulation sequences for each participant will be conducted by this external individual. Additionally, to blind participants to the type of stimulation in each session, the tDCS device will be concealed from view using a cover, and the principal investigator will not be present in the laboratory during electrode placement, throughout the 20-minute stimulation period, or during electrode removal. N/A This study involves healthy male physical education students aged 18–29 years with no cardiovascular, pulmonary, metabolic, neurological, musculoskeletal, or visual disorders. The research does not study a specific disease but examines neuromodulation effects on endurance and cognitive performance in a healthy, physically active population.. Intervention 1: Intervention group 1: Participants will receive anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (L-DLPFC) with the anode at F3 and the cathode at AF4, at 2 mA intensity for 20 minutes. Intervention 2: Intervention group 2: Participants will receive anodal transcranial pulsed current stimulation (tPCS) over the left dorsolateral prefrontal cortex (L-DLPFC) with the same electrode placement, at 1.5 mA intensity for 20 minutes. Intervention 3: Control group: Participants will receive sham stimulation with identical electrode placement; however, current will be delivered for only the first 30 seconds and then stopped, mimicking the sensation without providing actual stimulation. 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 No further information available.
public Vahid Tadibi
Razi University, Bagh Abrisham blvd
Kermanshah Iran (Islamic Republic of) 6714414874 +98 83 3427 7609 vtadibi@yahoo.com Razi University scientific Vahid Tadibi
Razi University, Bagh Abrisham blvd
Kermanshah Iran (Islamic Republic of) 6714414874 +98 83 3427 7609 vtadibi@yahoo.com Razi University Iran (Islamic Republic of) Age range: 18–29 years Male physical education students at Razi University, third semester or higher Body mass index (BMI): 18.5–24.9 kg/m² Right-handed 18 years 29 years Male Presence of any cardiovascular, pulmonary, or metabolic disease History of seizures, epilepsy, or other neurological disorders Presence of implanted medical devices or pacemakers Use of tobacco or alcohol Color blindness or other visual impairments Treatment - Devices Treatment - Devices Placebo Intervention group 1: Participants will receive anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (L-DLPFC) with the anode at F3 and the cathode at AF4, at 2 mA intensity for 20 minutes. Intervention group 2: Participants will receive anodal transcranial pulsed current stimulation (tPCS) over the left dorsolateral prefrontal cortex (L-DLPFC) with the same electrode placement, at 1.5 mA intensity for 20 minutes. Control group: Participants will receive sham stimulation with identical electrode placement; however, current will be delivered for only the first 30 seconds and then stopped, mimicking the sensation without providing actual stimulation. The primary outcome variable is the endurance performance, specifically measured as the time to exhaustion on ergometer cycling test. This is the main variable expected to change as a result of the interventions (tDCS, tPCS, or sham), and it is the outcome used for calculating the sample size. Timepoint: The primary outcome (endurance performance – time to exhaustion) is measured once in each experimental session, immediately after the application of the intervention (tDCS, tPCS, or sham). There is no multiple follow-up measurements planned — the timepoint is directly after intervention within the same session. Method of measurement: The primary outcome variable, namely endurance performance, will be assessed using a cycling test time to exhaustion on a cycle ergometer (Cyclus). During the initial session, participants’ peak power output will be determined by performing an incremental exercise test. In the three main experimental sessions, participants will be required to cycle at 85% of their determined peak power output until exhaustion, and the time to exhaustion will be recorded as the indicator of endurance performance. Razi University Approved 2025-07-02 Ethics committee of Razi University Razi University, Bagh Abrisham blvd, Kermanshah Kermanshah Iran (Islamic Republic of)