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IRCT20210617051606N8 IRCT 2023-02-09 Razi University Effects of exercise training and brain stimulation on drug dependency Evaluating the Effect of Transcranial Direct Current Stimulation and Circuit Training on Drug Craving, Impulsivity, and Risky Decision-Making in Females with Drug Dependency during Rehabilitation Period 2023-02-15 anticipated 16 Complete https://irct.ir/trial/68477 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, the order of subjects' exposure to 4 different conditions will be randomized by the Latin Squares method. To do so, first, using the www.random.org website, a number between 1 and 16 will be randomly allocated to each subject as an identification code. Then, the English letters A, B, 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 will be placed in the sequence of the first row, participants number 5 to 8 will be placed in the sequence of the second row, participants number 9 to 12 will be placed in the sequence of the third row and, participants number 13 to 16 will be placed in the sequence of the fourth row, Blinding description: In this double-blind study, the investigator and the participants will be blinded to the type of transcranial electrical stimulation used in the four experimental conditions. In the current study, the Neurostim stimulation device will be used to induce direct current electrical stimulation in two types including 1) anodal and 2) sham in four experimental conditions. For this purpose, an individual outside the research team who is thoroughly familiar with using the brain stimulation device will be responsible for applying the stimulation in experimental sessions. In order to blind the participants, after they sit on a special chair, the stimulating device is hidden from their view 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, the induction of brain stimulation will be done without the presence of the researcher and the relevant information will be available to the same person outside the research team. 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. Then the current is cut off and the stimulation is deactivated, but the electrodes will remain on the head until the end of the same time as the anodal stimulation. N/A Drug abuse. Intervention 1: Intervention group: In this study, all the subjects were exposed to three intervention conditions with an interval of at least one week in between. These conditions include 1) circuit training+ anodal stimulation of the dorsolateral prefrontal cortex, 2) circuit training+ sham stimulation, and 3) anodal stimulation of the dorsolateral prefrontal cortex. Circuit training will consist of a standard 5-7 minute warm-up followed by 4 sets of circuit training. Each set consists 8 stations including bodyweight squats, crawls, bench dips, frog jumps, sit-ups, push-ups, moving lunges, and back hyperextensions. Subjects will perform the prescribed exercise for 40 seconds at each station. Subjects will be asked to do their best in 40 seconds to perform the prescribed exercise correctly and as much as possible. There will be a 20 second rest between each station. 20 minutes with 2 milliamperes will be used to stimulate the target area in the brain. For this purpose, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the international brain mapping system 10-20 and the target area is stimulated using two special stimulation electrodes and a special electroencephalogram cap. In intervention conditions, the study variables will be measured before interventions, and then the subjects will receive brain stimulation and then perform the prescribed exercise. After the end of the exercise, the study variables are measured again. Intervention 2: Control group: In this study, in addition to three intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes. Yes - There is a plan to make this available What will be shared: All data are shared after the de-identification of the participants When: 3 months after publication To whom: All individuals upon formal request Conditions: Data sharing requests are accepted for any purposes Where to obtain: To obtain any data/documents, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir How to obtain: Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail Comments:
public Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University scientific Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University Iran (Islamic Republic of) Aged between 18 to 50 years Resident of Kermanshah Not taking the drug for 2 to 12 months Being right handed History of drug abuse and being in the phase of rehabilitation Absence of physical drug dependency (participating in detoxification) Getting the certification of no prohibition of participating in the exercise training program from a specialist 18 years 50 years Female History of seizures, epilepsy, or other neurological diseases Existence of implantable devices or pacemakers in the body Tobacco and alcohol consumption Existence of ant musculoskeletal disorders Participation in regular exercise training program in last 6 months Z71.5 Drug abuse counseling and surveillance Treatment - Devices Placebo Intervention group: In this study, all the subjects were exposed to three intervention conditions with an interval of at least one week in between. These conditions include 1) circuit training+ anodal stimulation of the dorsolateral prefrontal cortex, 2) circuit training+ sham stimulation, and 3) anodal stimulation of the dorsolateral prefrontal cortex. Circuit training will consist of a standard 5-7 minute warm-up followed by 4 sets of circuit training. Each set consists 8 stations including bodyweight squats, crawls, bench dips, frog jumps, sit-ups, push-ups, moving lunges, and back hyperextensions. Subjects will perform the prescribed exercise for 40 seconds at each station. Subjects will be asked to do their best in 40 seconds to perform the prescribed exercise correctly and as much as possible. There will be a 20 second rest between each station. 20 minutes with 2 milliamperes will be used to stimulate the target area in the brain. For this purpose, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the international brain mapping system 10-20 and the target area is stimulated using two special stimulation electrodes and a special electroencephalogram cap. In intervention conditions, the study variables will be measured before interventions, and then the subjects will receive brain stimulation and then perform the prescribed exercise. After the end of the exercise, the study variables are measured again. Control group: In this study, in addition to three intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes. Changes in drug craving. Timepoint: Before and after interventions. Method of measurement: Drug craving standard questionnaire. Changes in impulsivity. Timepoint: Before and after interventions. Method of measurement: Go/ No Go cognitive test software. Risky decision-making. Timepoint: Before and after interventions. Method of measurement: IOWA gambling cognitive test software (This name is not an abbreviation and is the original name of the test). Changes in pleasure sensation. Timepoint: Before and after interventions. Method of measurement: 11-point pleasure sensation scale. Changes in arousal. Timepoint: Before and after interventions. Method of measurement: 6-point felt arousal scale. Razi University Approved 2022-04-27 Research Ethics Committees of Kermanshah Razi University Room. 73, Faculty of Sport Sciences, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)