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IRCT20190612043877N1 IRCT 2022-06-13 Qazvin University of Medical Sciences The Efficacy of Magnetic Stimulation in Patients with Major Depressive Disorder The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients with Major Depressive Disorder Resistant to First-line Pharmaceutical Therapy: A Double-blinded Randomized Clinical Trial 2022-06-02 anticipated 60 Complete https://irct.ir/trial/63919 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: The block randomization method will assign patients to the intervention (active rTMS) and control (sham rTMS) groups. In this randomization method, the number of people assigned to each group is usually almost equal. The size of each block can be 5 to 10 people. In this way, for example, one type of rTMS is given to the first block, another to the second, and so on. Eligible patients will be allocated via concealed assignments using the sealed envelope method, Blinding description: This study will be performed double-blind and researchers and patients will be blind to this allocation. Depression assessors who review rTMS will also be blind to patient allocation. After completing the study and collecting the results, the relevant codes will be provided to each patient by a specialized team, and the implementation of the double-blind nature of the study was such that neither the participants nor the depression assessor is aware of the patient allocation. 3 Major Depressive Disorder Resistant to First-line Pharmaceutical Therapy. Intervention 1: • The rTMS protocol is performed by a MagVenture device (Denmark) with an 8-shaped coil equipped with a cooling system. Before each rTMS session, participants' motor threshold (MT) is determined by detecting the lowest stimulus energy level required to stimulate the motor cortex and producing five consecutive contractions of the right abductor pollicis brevis (APB) muscle. Stimulation is applied to the left DLPFC. The stimulation location in each participant is determined by moving the coil 5 cm anterior to the optimal surface location for activation of the right APB muscle. The experimental group will receive ten sessions of rTMS for two weeks, and the control group will receive sham rTMS for ten sessions. For more certainty, the positioning of the coil based on the stereotactic systems is also examined. 10 Hz frequency, 5 seconds stimulation, 10 seconds interruption, and 75 pulse trains is performed. 3750 pulses is applied in each session, and 37,500 pulses will be applied on the left during ten sessions. Stimulation is applied at 110% of the resting MT. Intervention 2: Control group: Sham stimulation will be performed using an rTMS device with a sham coil, which is not creating any tactile sensation at the stimulation site and does not induce any cortical stimulation. The sham device provided a matching acoustic feel. Each participant receives ten rTMS sessions daily, regardless of the assigned group. Each treatment session will last 18 minutes. To eliminate external confounding effects and prevent bias, sham rTMS is delivered along with active rTMS using the same equipment so that patients can hear the device's voice. Still, no magnetic current will be discharged to the brain. Yes - There is a plan to make this available What will be shared: After coding and unidentifiable, patients are shared based on the main consequences associated with the disease When: Start access valley one year after printing results To whom: Researchers at General Medical Universities Conditions: For scientific exploitation Where to obtain: Ali Akbar Shafikhani, Qazvin University of Medical Sciences, ali.shafikhani@yahoo.com How to obtain: Send an email explaining the reason for the request Comments:
public Alireza Haji Seyed Javadi
خیابان راه آهن، بیمارستان ۲۲ بهمن
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3355 5054 ahsjavadi@qums.ac.ir Qazvin University of Medical Sciences scientific Alireza Haji Seyed Javadi
Railway Street, 22 Bahman Hospital
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3355 5054 ahsjavadi@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria were the age of 18 to 70 years Primary diagnosis of MDD by a psychiatrist based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders version V (DSM-V). the patients whose MDD was approved by a specialist according to MDD criteria and who had received and failed to respond to an episode of treatment (for at least six weeks) with effective tolerated doses of antidepressants were included in the study. The patients should have received the same medication from six weeks to the onset of the study and continued taking the drug during the study. Exclusion criteria comprised the presence of underlying diseases History of rTMS treatment due to any disorder History of seizures or neurosurgery, Having a pacemaker Pregnancy Being diagnosed with a high risk of suicide, substance abuse, and unwillingness to participate in the study. 18 years 70 years Both Major Depr F33 Treatment - Devices Treatment - Devices • The rTMS protocol is performed by a MagVenture device (Denmark) with an 8-shaped coil equipped with a cooling system. Before each rTMS session, participants' motor threshold (MT) is determined by detecting the lowest stimulus energy level required to stimulate the motor cortex and producing five consecutive contractions of the right abductor pollicis brevis (APB) muscle. Stimulation is applied to the left DLPFC. The stimulation location in each participant is determined by moving the coil 5 cm anterior to the optimal surface location for activation of the right APB muscle. The experimental group will receive ten sessions of rTMS for two weeks, and the control group will receive sham rTMS for ten sessions. For more certainty, the positioning of the coil based on the stereotactic systems is also examined. 10 Hz frequency, 5 seconds stimulation, 10 seconds interruption, and 75 pulse trains is performed. 3750 pulses is applied in each session, and 37,500 pulses will be applied on the left during ten sessions. Stimulation is applied at 110% of the resting MT. Control group: Sham stimulation will be performed using an rTMS device with a sham coil, which is not creating any tactile sensation at the stimulation site and does not induce any cortical stimulation. The sham device provided a matching acoustic feel. Each participant receives ten rTMS sessions daily, regardless of the assigned group. Each treatment session will last 18 minutes. To eliminate external confounding effects and prevent bias, sham rTMS is delivered along with active rTMS using the same equipment so that patients can hear the device's voice. Still, no magnetic current will be discharged to the brain. Depression symptoms. Timepoint: At baseline (before intervention) and the second and fourth weeks after intervention. Method of measurement: The Hamilton Rating Scale. Severity of the disease. Timepoint: At baseline (before intervention) and the second and fourth weeks after intervention. Method of measurement: Clinical Global Impression–Severity scale (CGI-S). Illness Perception. Timepoint: At baseline (before intervention) and the second and fourth weeks after intervention. Method of measurement: the Brief Illness Perception Questionnaire (Brief IPQ). Qazvin University of Medical Sciences Approved 2022-05-30 The ethics committee of Qazvin University of Medical Sciences Shahid Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)