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IRCT20230508058128N1 IRCT 2023-05-10 Kerman University of Medical Sciences The effect of Repetitive transcranial magnetic stimulation (r-TMS) in the Dorsolateral Prefrontal Cortex (DLPFC) on the symptoms of patients with obsessive-compulsive disorder The effect of Repetitive transcranial magnetic stimulation (r-TMS) in the Dorsolateral Prefrontal Cortex (DLPFC) on the symptoms of patients with obsessive-compulsive disorde 2023-05-15 anticipated 40 Complete https://irct.ir/trial/70023 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2, Blinding description: Grouping of patients will be done based on random sampling and in 2 groups A and B. Both groups will be exposed to similar interventions; with the difference that the control group will only be subjected to the standard drug regimen and Sham will be used for them; So that the device will be placed on the patient's scalp without magnetic stimulation. The patients and the statistical analyst were not aware of the treatment method in detail and only knew of their group. 3 Obsessive-compulsive disorder. Intervention 1: Intervention group: standard drug treatment + treatment using magnetic stimulation of the brain with rTMS device - during 4 weeks treatment with magnetic stimulation of the brain with rTMS device model Standard Rapid2 (Magstim company) as follows: left DLPFC/OFC stimulated - Orientation 135 degrees - 12 sessions, 3 times a week+ Drug treatment with sertraline. Intervention 2: Control group: only the standard drug treatment of the disease (drug treatment will be done with sertraline) + the control group will also be subjected to only drug treatment with a standard regimen (under the supervision of a doctor who is a member of the scientific board), Sham will be used for them, so that the device It will be placed on their scalp without magnetic stimulation. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Start access when the article is published To whom: It will be available for researchers working in academic and scientific institutions. Conditions: The researcher will be available for further analysis and review studies upon request to ensure the accuracy of the data. Where to obtain: Researcher responsible for the project - email address: mahineslami@yahoo.com, contact number: +98 34 1211 6328, postal address: 7618834115 How to obtain: In case of contacting the researcher responsible for the project and confirming the identity of the people, the data will be provided to them within 1 week. Comments:
public Zahra Rajabi Bahabadi
Islamic Republic Boulevard, Alley 27
Kerman Iran (Islamic Republic of) 7618833639 +98 34 3211 6330 rajabizhra68@gmail.com Kerman University of Medical Sciences scientific Dr. Mohin Eslami Shahrbabaki
Shahid Beheshti Hospital, Islamic Republic Blvd., Kerman, Iran
Kerman Iran (Islamic Republic of) 7618834115 +98 34 1211 6328 mahineslami@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of OCD based on the DSM V diagnostic criteria by two psychiatrists (clinical interview) obtaining a score equal to or greater than 16 from the Y-BOCS questionnaire, not taking related drugs in the last four weeks and starting drug treatment with sertraline 150 mg (simultaneously to along with r-TMS for the intervention group), not receiving ECT in the past 6 months and the willingness of the subjects to participate in the research 18 years 60 years Both Existence of accompanying psychiatric disorder, especially depression (based on Beck Depression Scale) score of Beck Questionnaire above 10, suffering from seizures use of drugs and substances, presence of metal implants, pacemaker, trauma or head injury and neurosurgery procedures incompleteness of patients data more than 10% F42 Obsessive-compulsive disorder Treatment - Devices Treatment - Drugs Intervention group: standard drug treatment + treatment using magnetic stimulation of the brain with rTMS device - during 4 weeks treatment with magnetic stimulation of the brain with rTMS device model Standard Rapid2 (Magstim company) as follows: left DLPFC/OFC stimulated - Orientation 135 degrees - 12 sessions, 3 times a week+ Drug treatment with sertraline Control group: only the standard drug treatment of the disease (drug treatment will be done with sertraline) + the control group will also be subjected to only drug treatment with a standard regimen (under the supervision of a doctor who is a member of the scientific board), Sham will be used for them, so that the device It will be placed on their scalp without magnetic stimulation. Yale-Brown Obsession Scale. Timepoint: Before the start of the study, after each RTMS session, 3 months after the last session. Method of measurement: Using a standard questionnaire. Quality of Life Brief Version (WHOQOL-BREF). Timepoint: Before the intervention, after each session, 3 months after the last session. Method of measurement: Based on a standard questionnaire. Symptoms of obsession. Timepoint: Before the intervention, after each session, 3 months after the last session. Method of measurement: Based on a standard questionnaire. Beck depression questionnaire 2. Timepoint: Before the intervention, after each session, 3 months after the last session. Method of measurement: Based on a standard questionnaire. Kerman University of Medical Sciences Approved 2023-02-12 Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Scineces Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus Kerman Kerman Iran (Islamic Republic of)