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IRCT20220904055869N1 IRCT 2022-10-06 Shiraz University of Medical Sciences Effect of forehead cooling on cognitive functions. CTSD DEVELOPMENT OF A CORTICAL-THERMAL STIMULATION DEVICE (CTSD) TO REGULATE FRONTOPOLAR TEMPERATURE AND THE EXAMINATION OF ITS EFFECTS ON COGNITIVE FUNCTIONS; A PSYCHOMETRIC VALIDATION APPROACH 2022-04-07 anticipated 40 Complete https://irct.ir/trial/65906 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: This study is a randomized clinical trial (phase 2-3 study) in which subjects were assigned to sham (control group) or true (intervention group) CTSD intervention through simple randomization in 1:1 ratio. We wrote the numbers 1-40 on papers of the same size and put them in a closed paper envelope. Then, after the participant agreed to participate in the study, we randomly picked a number from the envelope. If the number we picked was an even number, the participant was placed in the intervention group, and if there was an odd number, he/she was placed in the control group, Blinding description: How to conduct the study (use of Cortical Thermal Stimulating Device) and how the device works were explained to the participants and the informed consent form was completed, but during the study, the intervention group received the device ON and the control group as a sham (that is, the device turns off automatically after thirty seconds). 2-3 The regulation of frontopolar temperature to enhancement of cognitive functions in healthy adults.. Intervention 1: Intervention group: This study was conducted in 6 half-hour sessions, with a 24-hour interval between each session, and in each session the Cortical Thermal Stimulation Device was used for the participants. the Cortical Thermal Stimulation Device (made in the Department of Neurosciences of Shiraz University of Medical Sciences) has a headband part that is tied on the forehead of people and when the device is on, the temperature of the headband is in a certain temperature is kept constant, and in this study, for the intervention group, the device is placed on the forehead of the people for 30 minutes and keeps the temperature of this area constant at 34 degrees Celsius. It should be noted that this temperature was chosen based on previous studies. Intervention 2: Control group: according to the intervention group, the headband of the Cortical Thermal Stimulation Device is placed on the forehead of the people and the device is turned on, but in this group, thirty seconds after the start, the device is automatically turned off. Yes - There is a plan to make this available What will be shared: The results of part of the data will be reported in the form of an article, and the rest of the data (quantitative EEG and fNIRS) will also be used as a database for signal processing after deidentifying people. When: The access period starts 6 months after the results are published. To whom: Researchers working in academic and scientific institutions Conditions: Using information as a database and signal processing Where to obtain: Register action through roohollaz1991@yahoo.com How to obtain: Registering the request through the said email, identifying the person's identity and resume (to check employment in academic and scientific institutions), sending information Comments:
public Mohammad Nami
Unit 402, Floor 3, Mahyar apartment, 4 Alley, Esteghlal Blvd, Shiraz, IRAN
shiraz Iran (Islamic Republic of) 7173686674 +98 71 3230 0535 roohollaz1991@yahoo.com Shiraz University of Medical Sciences scientific Mohammad Nami
Unit 402, Floor 3, Mahyar apartment, 4 Alley, Esteghlal Blvd, Shiraz, IRAN
Shiraz Iran (Islamic Republic of) 7173686674 +98 71 3230 0535 roohollaz1991@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) No significant of cognitive impairment and head trauma stable medical condition The age range 18-40 years old Residence in Shiraz Being literate enough to cooperate with the examiners The point of Raven's Progressive Matrices would be above 90 18 years 40 years Both Observation of any neuropsychological disorder or medical illness Drug abuse or alcoholism Rehabilitation Placebo Intervention group: This study was conducted in 6 half-hour sessions, with a 24-hour interval between each session, and in each session the Cortical Thermal Stimulation Device was used for the participants. the Cortical Thermal Stimulation Device (made in the Department of Neurosciences of Shiraz University of Medical Sciences) has a headband part that is tied on the forehead of people and when the device is on, the temperature of the headband is in a certain temperature is kept constant, and in this study, for the intervention group, the device is placed on the forehead of the people for 30 minutes and keeps the temperature of this area constant at 34 degrees Celsius. It should be noted that this temperature was chosen based on previous studies. Control group: according to the intervention group, the headband of the Cortical Thermal Stimulation Device is placed on the forehead of the people and the device is turned on, but in this group, thirty seconds after the start, the device is automatically turned off. The score of healthy adults in CANTAB battery. Timepoint: First to sixth sessions for half an hour simultaneously with temperature stimulation. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB). The examination of oxygenated blood in the frontopolar area. Timepoint: Before and after the sessions 2-5 for three minutes. Method of measurement: functional Near InfraRed Spectroscopic (fNIRS). Brain map scores. Timepoint: Before and after the first and sixth session for 6 minutes. Method of measurement: quantitative Electroencephalogram. Shiraz University of Medical Sciences Approved 2022-01-11 Research Ethics Committees of Shiraz University of Medical Sciences No. 4, Esteghlal Blvd, Shiraz Town Shiraz Fars Iran (Islamic Republic of)