]>
IRCT20210211050329N1 IRCT 2021-03-02 Azarbaijan Shahid Madani University Effect of rTMS on Cognitive Function of Depressive Disorder 7 Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on depression severity, response inhibition, cognitive flexibility and visuo-spatial memory in patients with Depressive Disorder 2021-03-05 anticipated 50 Complete https://irct.ir/trial/54467 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple Randomization unit: individual Randomization tool: In separate sheets, we will write the names of all the participants in the study and will put them in a container, and then randomly will pick the names and will add the first one to the list of the unilateral stimulation group, the second to the list of the bilateral stimulation group, and the third to the control group list. We will continue this until the last person, Blinding description: Participants will not be explained whether they are in the intervention group or in the control group (blinding takes place), but due to the difference in stimulation areas in the two intervention groups, blinding between intervention groups is not possible for participants. Due to the difference in stimulation areas in the intervention groups and the difference in the stimulation angle in the control group and the intervention groups, blinding is impossible for the researcher. However, the data analyzer will be blind because he will receive only the list of data specified by a different code. And the person does not know which code is for which group—for example, the number 25 for a unilateral group. The number 35 will be assigned to the control group and the number 15 to the bilateral group, which in data analysis, the analyst will not be aware of the allocation of these numbers to the groups. N/A Depressive Disorder. Intervention 1: Intervention group: Stimulation will be performed by using a Magstim super-rapid magnetic stimulator (Wales, UK). The unilateral group will receive stimulation of Left DLPFC (20Hz, 5s in each train, 2100 pulses, and 85% of Motor Threshold) for 10 sessions during 2 weeks( 5 sessions each week). The coil will be placed at a 45-degree angle on the patient's scalp. Intervention 2: Intervention group 2: Stimulation will be performed by using a Magstim super-rapid magnetic stimulator (Wales, UK). The bilateral group will receive stimulation of left DLPFC (20Hz, 5s in each train, 1400 pulses, and 85% of Motor Threshold), followed by Right DLPFC stimulation (1Hz, 10s in each train, 700 pulses, and 110% of Motor Threshold) for 10 sessions during 2 weeks( 5 sessions each week). The coil will be placed at a 45-degree angle on the patient's scalp. Intervention 3: Control group: In the control group, we will perform artificial stimulation and for 10 sessions for 2 weeks( 5 sessions each week), but the coil will be placed at a 90-degree angle on the patient's scalp. So they will not receive any stimulation. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Fatemeh Asgharian Asl
Tabriz. valiar
Tabriz Iran (Islamic Republic of) 5158944399 +98 910 402 0414 fatemeh.asgharian@azaruni.ac.ir Azarbaijan Shahid Madani University scientific Fatemeh Asgharian asl
Valiasr, Tabriz
Tabriz Iran (Islamic Republic of) 5158944399 +98 41 3145 2406 fatemeh.asgharian@azaruniv.ac.ir Azarbaijan Shahid Madani University Iran (Islamic Republic of) Being right-hand Age between 25-45 Having physical health 25 years 45 years Both Being pregnant Having metal, prosthesis, implant or pacemaker Dependence on psychotropic substances History of Trauma or seizures in the individual or family Having other psychological disorders F32.2 Major depressive disorder, single episode, severe without psychotic features Treatment - Other Treatment - Other Placebo Intervention group: Stimulation will be performed by using a Magstim super-rapid magnetic stimulator (Wales, UK). The unilateral group will receive stimulation of Left DLPFC (20Hz, 5s in each train, 2100 pulses, and 85% of Motor Threshold) for 10 sessions during 2 weeks( 5 sessions each week). The coil will be placed at a 45-degree angle on the patient's scalp. Intervention group 2: Stimulation will be performed by using a Magstim super-rapid magnetic stimulator (Wales, UK). The bilateral group will receive stimulation of left DLPFC (20Hz, 5s in each train, 1400 pulses, and 85% of Motor Threshold), followed by Right DLPFC stimulation (1Hz, 10s in each train, 700 pulses, and 110% of Motor Threshold) for 10 sessions during 2 weeks( 5 sessions each week). The coil will be placed at a 45-degree angle on the patient's scalp. Control group: In the control group, we will perform artificial stimulation and for 10 sessions for 2 weeks( 5 sessions each week), but the coil will be placed at a 90-degree angle on the patient's scalp. So they will not receive any stimulation. Depression score in Beck questionnaire and clients' performance in cognitive functions of response inhibition, cognitive flexibility, and visual-spatial memory. Timepoint: Before the intervention and after two weeks. Method of measurement: By Beck Depression questionnaire and Clients' Performance in Cognitive Tasks of Go-Go, Corsi, and Wisconsin. Azarbaijan Shahid Madani University Approved 2020-02-17 Ethics committee of Tabriz University of Medical Sciences Abresan. Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)