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IRCT20240528061935N1 IRCT 2024-06-01 Islamic Azad University Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) with and without Physical Activity on Depressive Symptoms, Brain Map , Physical Condition and Sleep Quality of Depressed Patients Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) with and without Physical Activity on Depressive Symptoms, Brain Map , Physical Condition and Sleep Quality of Depressed Patients 2024-05-01 anticipated 45 Complete https://irct.ir/trial/77076 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to the intervention and control groups using the random block method. Then random replacement is done by lottery method (one number will be assigned to each of the sampled people). We write down the numbers on paper, then fold them and put them in a container. We mix and stir the papers completely. Then we take out the papers one by one and place one number in the first group and one number in the second group, respectively. Then random application will be done. In this way, one group is known as "control group" and the other group is known as "intervention group". In this way, to randomly determine the "control group" and the "intervention group", we put the set of each group in two separate envelopes and put them in a container. Then we randomly take one envelope out of the container and assign it to the "intervention group" and the other envelope to the "control group", Blinding description: Due to the fact that the patients do not know about the group assignment, a blind study is performed. 2-3 Major Depressive Disorder. Intervention 1: Intervention group: They will receive the rTMS protocol in addition to the usual treatment. The research was conducted in such a way that the subjects will be evaluated by the Beck depression test one week before rTMS. Then they will be treated with rTMS for 25 sessions (regularly on 5 days of the week) and for 20 minutes of magnetic stimulation in the dorsolateral area of ​​the prefrontal cortex of the left hemisphere (with the opinion of the attending physician). During the study, subjects will take their medicines without any changes. Checking the dose and the amount of medication and changing the drugs during the treatment period, if it occurs, will be excluded from the study. Intervention 2: Control group: rTMS will be received off. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identification. When: Data can be made available 6 months after results are published. To whom: Researchers in scientific and academic centers can access the data. Conditions: The data can be used in meta-analyses if the names of the main researchers are mentioned. Where to obtain: If you need data, write to firoozefadaee1@gmail.com. How to obtain: After receiving the request and its review by the main researcher, the data will be sent to the applicant along with a letter of commitment stating that the data will not be published without the name of the main researcher within one month. Comments:
public Firouze Fadaei Goke
Ali Mahmoudi Street, Qamiyeh Township
Eslamshahr Iran (Islamic Republic of) 3315865451 +98 21 5649 3166 firoozefadaee1@gmail.com Islamic Azad University, Semnan branch scientific Firouze Fadaei Goke
Ali Mahmoudi Street, Qamiyeh Township
Eslamshahr Iran (Islamic Republic of) 3315865451 +98 21 5649 3166 firoozefadaee1@gmail.com Islamic Azad University, Semnan branch Iran (Islamic Republic of) Minimum literacy to read and write Completing the patients' consent form to participate in the experiment Getting a score above 20 in the Beck depression Inventory No history of special diseases and mental illnesses Not taking psychotropic drugs No drug addiction No history of seizures and epilepsy Have a minimum age of 18 and a maximum age of 65 years 18 years 65 years Both Unwillingness to continue cooperation Failure to complete research questionnaires or filling them incompletely Having intracranial implants (shunts, stimulators, electrodes) and any other metal object near the head F32 Major depressive disorder, single episode Treatment - Devices Treatment - Drugs Intervention group: They will receive the rTMS protocol in addition to the usual treatment. The research was conducted in such a way that the subjects will be evaluated by the Beck depression test one week before rTMS. Then they will be treated with rTMS for 25 sessions (regularly on 5 days of the week) and for 20 minutes of magnetic stimulation in the dorsolateral area of ​​the prefrontal cortex of the left hemisphere (with the opinion of the attending physician). During the study, subjects will take their medicines without any changes. Checking the dose and the amount of medication and changing the drugs during the treatment period, if it occurs, will be excluded from the study. Control group: rTMS will be received off. Depression. Timepoint: Before and after 25 sessions of intervention. Method of measurement: Beck depression questionnaire is used to check depression. Quantitative electroencephalography. Timepoint: Before and after 25 sessions of intervention. Method of measurement: Quantitative electroencephalography measurement scale. Physical Condition. Timepoint: Before and after 25 sessions of intervention. Method of measurement: Lindenberg Physical Status Improvement Questionnaire. Sleep Quality. Timepoint: Before and after 25 sessions of intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. CD3 and CD4 levels. Timepoint: In the intervals before and immediately after receiving repetitive brain magnetic stimulation (rTMS) treatment. Method of measurement: Routine blood sample Test for CD3-CD4 level count. Islamic Azad University, Semnan Branch Approved 2024-04-30 Ethics Committee of Semnan Azad University Islamic Azad University, University Town, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)