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IRCT20250812066837N1 IRCT 2025-09-05 Vice-Chancellor for Research, Razi University Effects of tDCS Stimulation and Acetazolamide consumption on Exercise Performance Effects of transcranial direct current stimulation and acetazolamide consumption on exercise and cognitive performance, and physiological and perceptual responses of mountaineers in simulated altitude 2025-09-06 anticipated 12 Complete https://irct.ir/trial/85514 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 four different conditions, the Latin square method will be used. First, using the website www.random.org, each participant will be randomly assigned a number between 1 and 12 as an identification code. Then, the English letters A, B, C, D, E, and F will be assigned to the six intervention conditions, and a 6×6 Latin square will be created. After generating the Latin square, participants numbered 1 and 2 will follow the sequence of the first row, participants numbered 3 and 4 will follow the sequence of the second row, participants numbered 5 and 6 will follow the sequence of the third row, participants numbered 7 and 8 will follow the sequence of the fourth row, participants numbered 9 and 10 will follow the sequence of the fifth row, and participants numbered 11 and 12 will follow the sequence of the sixth row, Blinding description: The present study will be conducted in a double-blind manner. Neither the participants nor the principal investigator will be aware of the type of stimulation administered in each session, and this information will be accessible only to an individual outside the research team until the completion of the study. To conceal the stimulation order from the principal investigator, all procedures related to the random determination of the stimulation sequence for each participant will be carried out by the same individual outside the research team. Furthermore, to conceal the type of stimulation in each session from the participants, the tDCS device will be hidden from their view using a cover, and the principal investigator will not be present in the laboratory during electrode placement or at the end of the 20-minute session when the electrodes are removed. N/A Healthy Mountaineers. Intervention 1: Intervention 1 : Acetazolamide + stimulation of M1 Before each exercise session, participants must take seven 125 mg capsules of acetazolamide. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. Acetazolamide will be obtained from Mehr Darou Company, establishment license No. 91988/665. Acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the M1 and DLPFC areas, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the right M1, the anodal electrode will be placed over FC2, and the cathodal electrode will be placed on the left shoulder. For stimulation of the left DLPFC, the anodal electrode will be placed over F3, and the cathodal electrode will be placed over AF8. In the sham stimulation condition, the electrode placement will be similar to that of the DLPFC condition. Intervention 2: Intervention 2: Acetazolamide + stimulation of the DLPFC Before each exercise session, participants must take seven 125 mg capsules of acetazolamide. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. Acetazolamide will be obtained from Mehr Darou Company, establishment license No. 91988/665. Acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the DLPFC area, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the left DLPFC, the anodal electrode will be placed over F3, and the cathodal electrode will be placed over AF8. Intervention 3: Intervention 3: Acetazolamide + sham stimulation Before each exercise session, participants must take seven 125 mg capsules of acetazolamide. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. Acetazolamide will be obtained from Mehr Darou Company, establishment license No. 91988/665. Acetazolamide and placebo will be prepared in identical capsules. In the sham stimulation condition, electrode placement will be identical to that of the DLPFC stimulation condition. In sham stimulation, the current is ramped up for a few seconds and then decreased, producing sensations of itching and tingling similar to those experienced during active stimulation. In active stimulation, these sensations fluctuate as the participant adapts to the current, whereas in sham stimulation, the sensations disappear because the current is gradually stopped. Intervention 4: Intervention 4: Placebo + stimulation of M1 Before each exercise session, participants must take seven 125 mg capsules of placebo. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. The placebo will follow the same dosing protocol. The placebo will consist of lactose powder (seven 125 mg capsules). Both acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the M1 area, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the right M1, the anodal electrode will be placed over FC2, and the cathodal electrode will be placed on the left shoulder. Intervention 5: Intervention 5: Placebo + stimulation of DLPFC Before each exercise session, participants must take seven 125 mg capsules of placebo. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. The placebo will follow the same dosing protocol. The placebo will consist of lactose powder (seven 125 mg capsules). Both acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the DLPFC area, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the left DLPFC, the anodal electrode will be placed over F3, and the cathodal electrode will be placed over AF8. Intervention 6: Control group: Placebo + stimulation of sham stimulation Before each exercise session, participants must take seven 125 mg capsules of placebo. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. The placebo will follow the same dosing protocol. The placebo will consist of lactose powder (seven 125 mg capsules). Both acetazolamide and placebo will be prepared in identical capsules. In the sham stimulation condition, electrode placement will be identical to that of the DLPFC stimulation condition. In sham stimulation, the current is ramped up for a few seconds and then decreased, producing sensations of itching and tingling similar to those experienced during active stimulation. In active stimulation, these sensations fluctuate as the participant adapts to the current, whereas in sham stimulation, the sensations disappear because the current is gradually stopped. 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 At this stage, the data sharing policy has not been finalized. The decision will depend on ethical approval, participant consent, and the publication plan.
public Rezvan Kheirandish
No. 1, Razi University, University Street, Taq-Bostan, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7605 info@razi.ac.ir The Razi University of Kermanshah scientific Rezvan Kheirandish
No. 1, Razi University, University Street, Taq-Bostan, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7605 info@razi.ac.ir The Razi University of Kermanshah Iran (Islamic Republic of) Men aged 18 to 44 years Active mountaineers (with a history of ascents to altitudes above 4,000 meters and regular mountaineering activities in the past year) Regular aerobic training at least three sessions per week (including mountaineering and hiking) History of acute mountain sickness (AMS) during previous overnight stays at altitudes above 3,000 meters Obtaining a medical certificate of fitness for participation in the exercise training program 18 years 44 years Male Overnight stay at an altitude above 2,700 meters within two weeks prior to the start of the study Use of acetazolamide within two weeks prior to the start of the study Allergy to acetazolamide or sulfonamides Presence of any cardiovascular, pulmonary, or metabolic disease History of seizures, epilepsy, or other types of neurological disorders Presence of implanted medical devices or pacemakers Other Other Other Other Other Other Intervention 1 : Acetazolamide + stimulation of M1 Before each exercise session, participants must take seven 125 mg capsules of acetazolamide. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. Acetazolamide will be obtained from Mehr Darou Company, establishment license No. 91988/665. Acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the M1 and DLPFC areas, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the right M1, the anodal electrode will be placed over FC2, and the cathodal electrode will be placed on the left shoulder. For stimulation of the left DLPFC, the anodal electrode will be placed over F3, and the cathodal electrode will be placed over AF8. In the sham stimulation condition, the electrode placement will be similar to that of the DLPFC condition. Intervention 2: Acetazolamide + stimulation of the DLPFC Before each exercise session, participants must take seven 125 mg capsules of acetazolamide. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. Acetazolamide will be obtained from Mehr Darou Company, establishment license No. 91988/665. Acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the DLPFC area, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the left DLPFC, the anodal electrode will be placed over F3, and the cathodal electrode will be placed over AF8. Intervention 3: Acetazolamide + sham stimulation Before each exercise session, participants must take seven 125 mg capsules of acetazolamide. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. Acetazolamide will be obtained from Mehr Darou Company, establishment license No. 91988/665. Acetazolamide and placebo will be prepared in identical capsules. In the sham stimulation condition, electrode placement will be identical to that of the DLPFC stimulation condition. In sham stimulation, the current is ramped up for a few seconds and then decreased, producing sensations of itching and tingling similar to those experienced during active stimulation. In active stimulation, these sensations fluctuate as the participant adapts to the current, whereas in sham stimulation, the sensations disappear because the current is gradually stopped. Intervention 4: Placebo + stimulation of M1 Before each exercise session, participants must take seven 125 mg capsules of placebo. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. The placebo will follow the same dosing protocol. The placebo will consist of lactose powder (seven 125 mg capsules). Both acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the M1 area, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the right M1, the anodal electrode will be placed over FC2, and the cathodal electrode will be placed on the left shoulder. Intervention 5: Placebo + stimulation of DLPFC Before each exercise session, participants must take seven 125 mg capsules of placebo. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. The placebo will follow the same dosing protocol. The placebo will consist of lactose powder (seven 125 mg capsules). Both acetazolamide and placebo will be prepared in identical capsules. To precisely stimulate the DLPFC area, the international 10–20 EEG brain mapping system and a dedicated EEG cap will be used. According to the type of stimulation, the target areas for electrode placement will be marked using the EEG cap, and then the electrodes will be placed on the marked areas. For stimulation of the left DLPFC, the anodal electrode will be placed over F3, and the cathodal electrode will be placed over AF8. Control group: Placebo + stimulation of sham stimulation Before each exercise session, participants must take seven 125 mg capsules of placebo. Administration will begin three days before the start of the test (one capsule in the morning and one capsule in the evening), and on the morning of the test day, the capsule will be taken. The placebo will follow the same dosing protocol. The placebo will consist of lactose powder (seven 125 mg capsules). Both acetazolamide and placebo will be prepared in identical capsules. In the sham stimulation condition, electrode placement will be identical to that of the DLPFC stimulation condition. In sham stimulation, the current is ramped up for a few seconds and then decreased, producing sensations of itching and tingling similar to those experienced during active stimulation. In active stimulation, these sensations fluctuate as the participant adapts to the current, whereas in sham stimulation, the sensations disappear because the current is gradually stopped. Continuous Performance Test (CPT). Timepoint: During exercise. Method of measurement: Computerized Continuous Performance Test (CPT). EMG amplitude. Timepoint: During exercise. Method of measurement: 16-channel wireless electromyography (EMG) device (Noraxon, Scottsdale, AZ 85260, Germany. Choice reaction time. Timepoint: After brain stimulation, after exercise. Method of measurement: Choice Reaction Time Apparatus, Model (Indiana, Lafayette, 63035A, Panel Respon). Time to exhaustion. Timepoint: During exercise. Method of measurement: Running on a treadmill until reaching 90% of maximum heart rate or a rating of 19 on the Borg Rating of Perceived Exertion scale. SpO2. Timepoint: During brain stimulation, During fatiguing exercise. Method of measurement: Pulse oximeter (Nonin, USA). Stroop Color–Word. Timepoint: After brain stimulation, after exercise. Method of measurement: Computerized Stroop Test. Borg Rating of Perceived Exertion. Timepoint: During fatiguing exercise. Method of measurement: Borg Rating of Perceived Exertion (RPE) scale, 6–20. Sense of pleasure. Timepoint: During fatiguing exercise. Method of measurement: The Feeling Scale (FS; ranging from –5 to +5) was used, with responses recorded on a 5-point Likert-type scale. Felt Arousal Scale. Timepoint: During fatiguing exercise. Method of measurement: The Felt Arousal Scale (FAS; ranging from +1 to +6) was used, and its mean scores were analyzed on a 6-point Likert-type scale. Heart rate. Timepoint: During fatiguing exercise. Method of measurement: Polar heart rate monitor. Y-Balance. Timepoint: After brain stimulation, after exercise. Method of measurement: The maximum reach of the stance and non-stance leg was measured in three specified directions: (1) anterior, (2) posteromedial, and (3) posterolateral. Vice-Chancellor for Research, Razi University Approved 2023-02-01 Ethics Committee of Biomedical Research, Razi University No. 1, Razi University, University Street, Taq-Bostan, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)