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IRCT20211029052909N1 IRCT 2021-12-11 Zanjan University of Medical Sciences Evaluation of the therapeutic effect of rTMS on negative symptoms in schizophrenic patients Effectiveness of repetitive transcranial magnetic stimulation on negative symptoms in schizophrenic patients 2022-04-04 anticipated 66 Complete https://irct.ir/trial/59803 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. 66 patients will be selected to participate in the study by being available and passing the admission conditions. But assigning them to each treatment group will be simple randomization. For randomization with the help of Excel software by generating binomial distribution and 50% probability for n = 66 we produce codes 0 and 1. In this way, 33 codes 0 and 33 codes 1 are generated equally. Each participant gets a 0 or 1 code completely randomly and with a 50% probability. Code 0 is considered as the control group and code 1 is considered as the intervention group. In this way, the type of treatment for each person before entering the study and observation is determined by each member of the research team, Blinding description: The study is double blind. This means that the researcher and the patient do not know the type of treatment. Due to the fact that the treatment can be performed on the patient by the rTMS operator, the double blind condition can be applied accurately. It is noteworthy that due to the double blind of the study, only the rTMS operator and the statistician know how to codify and assign patients. Patients have already read and signed the informed consent form. All patients are connected to the rTMS device and the cap of the device is placed on their head. No patient is aware of the type of stimulation (active or sham). The rTMS operator knows the type of stimulation. For patients receiving active stimulation, the device is set to 10 Hz. For patients receiving sham stimulation, the device is set to 0 Hz. N/A Schizophrenia. Intervention 1: Intervention group: Patients were treated with active rTMS. 15 active rTMS sessions with a frequency of 10 Hz, 3 times a week for 5 consecutive weeks. The cap of the device is placed on the patient's head and they receive stimulation in the lateral dorsolateral prefrontal cortex. Intervention 2: Control group: Patients were treate with sham. Patients connect to the rTMS device and the cap of the device is placed on the patients' heads, but they receive sham stimulation. 15 sham rTMS session with a frequency of 0 Hz, 3 times a week for 5 consecutive weeks. Yes - There is a plan to make this available What will be shared: The data can be published after the individuals are not identified When: When publishing results To whom: Researchers working in academic and scientific institutions Conditions: For scientific research Where to obtain: Library of Zanjan University of Medical Sciences How to obtain: Visit the university library Comments:
public Elham Faghihzadeh
Mahdavi blv
Zanjan Iran (Islamic Republic of) 4513615788 +98 912 608 0676 e.faghihzadeh@zums.ac.ir Zanjan University of Medical Sciences scientific Ahmad Zolghadriha
Darvazeh Arg
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4001 ahmad_zolghadriha@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with schizophrenia with negative symptoms Be treated with antipsychotics The patient is in the maintenance phase 18 years 60 years Both Depression Seizure Pregnancy F20 Schizophrenia Treatment - Other Treatment - Other Intervention group: Patients were treated with active rTMS. 15 active rTMS sessions with a frequency of 10 Hz, 3 times a week for 5 consecutive weeks. The cap of the device is placed on the patient's head and they receive stimulation in the lateral dorsolateral prefrontal cortex. Control group: Patients were treate with sham. Patients connect to the rTMS device and the cap of the device is placed on the patients' heads, but they receive sham stimulation. 15 sham rTMS session with a frequency of 0 Hz, 3 times a week for 5 consecutive weeks. Negative symptoms in schizophrenic patients like poverty of speech, apathy, social withdrawal. Timepoint: One day before starting treatmentŲŒ One day after the end of treatment, Three weeks after the end of treatment. Method of measurement: The Positive and Negative Syndrome Scale (PANSS). Score obtained from Positive and Negative Syndrome Scale. Timepoint: One day before starting treatmentŲŒ, One day after the end of treatment, Three weeks after the end of treatment. Method of measurement: PANSS. Zanjan University of Medical Sciences Approved 2021-09-21 Ethics committee of Zanjan University of Medical Sciences Darvazeh Arg Zanjan Zanjan Iran (Islamic Republic of)