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IRCT20230806059051N1 IRCT 2023-11-14 Mazandaran University of Medical Sciences Investigating of the effects of electrical stimulation on the DLPFC region on risky decision making behavior and brain waves pattern following craving induction in smokers: A cognitive and computational approach Investigating of the effects of electrical stimulation on the DLPFC region on risky decision making behavior and brain waves pattern following craving induction in smokers: A cognitive and computational approach 2023-08-23 anticipated 63 Complete https://irct.ir/trial/72660 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Each of the eligible people, randomly and using the minimization method, are allocated in one of the four groups receiving multi-site electrical stimulation. QMinim program (web version of MinimPy software) is used to carry out the process of random allocation using the minimization method. In the minimization method, the first person randomly enters one of the four groups with equal probability. From the second person onwards, participants enter groups with unequal probability (in favor of the group that has the least balance with other groups in terms of the desired variables). This process is done in such a way, that by allocating each participant, the most possible balance is achieved in the distribution of the desired variables among the groups, and at the same time, the number of people in each group is as equal as possible. In this study, the basic probability of each person being in a group with the least balance (compared to other groups) is 85%, Blinding description: In this study, the participants are blind on the one hand, that is, they do not know about the type and process of stimulation, and the analyst also does not know about the type and process of stimulation. N/A People who smoke. Intervention 1: Intervention group: In this group, smokers received 20-minute TDCS electrical stimulation with an intensity of 2 mA in the left DLPFC region, and the cathode electrode was placed in the right part. Intervention 2: Intervention group: In this group, smokers received 20-minute TDCS electrical stimulation with an intensity of 2 mA in the right DLPFC area, and the anode electrode was placed on the right side. Intervention 3: Control group: A group of smokers who only had stimulation electrodes placed in the DLPFC region for 30 seconds. (sham group). 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 There is no more information
public Hamed ghazvini
Faculty of Modern Medical Technologies, Mazandaran University of Medical Sciences, Km 18 Khazarabad Road, Sari, Mazandaran, Iran
sari Iran (Islamic Republic of) 4815733971 ۳۳۵۴۳۳۵۶ Hghazvini1@gmail.com Mazandaran University of Medical Sciences scientific Hamed ghazvini
Faculty of Modern Medical Technologies, Mazandaran University of Medical Sciences, Km 18 Khazarabad Road, Sari, Mazandaran, Iran
sari Iran (Islamic Republic of) 4815733971 +98 911 393 3391 Hghazvini1@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Having informed consent Age 18 to 60 years Smoking at least 10 cigarettes a day Knowing the Persian language (Persian or Mazandarani dialect) Being a smoker for at least 2 years Not having a psychiatric diagnosis (schizophrenia-mania-bipolar disorders-major depression) Absence of head injury or any brain damage and neurological problems, for example, having a history of epilepsy, seizures, stroke, and brain or spinal cord tumors. Absence of any visual impairment Not implanting a metal object in the head Lack of simultaneous participation in another study 18 years 45 years Both Occurrence of any uncomfortable physical symptoms during the test History of suffering from any type of physical disease such as multiple sclerosis, diabetes, heart, lung, liver, kidney diseases and suffering from any acute infection. History of any type of psychiatric illness History of seizures for any reason Has taken psychiatric and anticonvulsant drugs in the last 3 months History of drug and alcohol use History of accidents and head trauma Sleep deprivation the night before the visit Drink tea and caffeine at least 3 hours before the cognitive test Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: In this group, smokers received 20-minute TDCS electrical stimulation with an intensity of 2 mA in the left DLPFC region, and the cathode electrode was placed in the right part. Intervention group: In this group, smokers received 20-minute TDCS electrical stimulation with an intensity of 2 mA in the right DLPFC area, and the anode electrode was placed on the right side. Control group: A group of smokers who only had stimulation electrodes placed in the DLPFC region for 30 seconds. (sham group) Craving scale. Timepoint: Before the start of the intervention and after the start of the intervention. Method of measurement: Nicotine craving scale. Mazandaran university of medical sciences Approved 2023-04-16 Ethics committee of Mazandaran University of Medical Sciences Faculty of Modern Medical Technologies, Mazandaran University of Medical Sciences, Km 18 Khazarabad Road, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)