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IRCT20190404043159N4 IRCT 2021-10-09 Esfahan University of Medical Sciences Comparison of the effect of TDCS and RTMS in the treatment of migraine Evaluation of the effectiveness of treatment with Trans cranial direct current stimulation in comparison with Repetitive Trans cranial Magnetic Stimulation in improving pain, anxiety, depression and quality of life in patients with migraine 2021-10-23 anticipated 72 Complete https://irct.ir/trial/59135 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The double random blocks method is used for randomization. In this way, both eligible patients are placed in a block and are arranged according to the national code, and a table of random numbers is used to determine the placement of patients in groups A or B. Numbers 0 to 4 will be in group A and numbers 5 to 9 will be in group B. Then, by tossing a coin, treatment method A is assigned to one method and B to the other treatment method. N/A Migraine. Intervention 1: Intervention group: Patients with migraine will be treated with electrical stimulation by the TDCS method with a intensity of 2 mA in the Dorsolateral Prefrontal cortex, in twelve sessions, every other day. Intervention 2: Intervention group: Patients with migraine treated with magnetic stimulation by RTMS method, with a frequency of 10 Hz, 600 pulses in 10 trains for 412 seconds and 70% of the stimulation threshold of each person in the Dorsolateral Prefrontal cortex,in three sessions, every other day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mohammad Reza Sharbafchi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Reza Sharbafchi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All 18 to 60 years old migraine patients with the code (ICHS-II 1.2.1) according to the International Classification of Headache Disorders (2004) and with a history of migraine attacks (of any severity) during a recent year that is confirmed by a neurologist. Conscious consent to participate in the study Have a minimum literacy 18 years 60 years Both A serious suicide plan or thoughts Pregnancy or Breastfeeding Substance abuse A history of seizures or any neurological disease (other than Migraine) Having a Pacemaker or any metal Implants in the upper limbs or head and neck History of any brain stimulation such as ECT(Electroconvulsive therapy) 7. History of taking antidepressants and anti-anxiety drugs from two months before entering the study Depressive, Bipolar, or Psychotic disorders based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders ) Criteria during examination by a Psychiatrist and Psychiatric Assistant G43 Migraine Treatment - Devices Treatment - Devices Intervention group: Patients with migraine will be treated with electrical stimulation by the TDCS method with a intensity of 2 mA in the Dorsolateral Prefrontal cortex, in twelve sessions, every other day. Intervention group: Patients with migraine treated with magnetic stimulation by RTMS method, with a frequency of 10 Hz, 600 pulses in 10 trains for 412 seconds and 70% of the stimulation threshold of each person in the Dorsolateral Prefrontal cortex,in three sessions, every other day. Pain intensity based on Visual Analogue Scale (VAS). Timepoint: At the beginning of the study and one month after the intervention. Method of measurement: Pain intensity based on Visual Analogue Scale (VAS). Depression score. Timepoint: At the beginning of the study and one month after the intervention. Method of measurement: Based on the Hospital Anxiety and Depression Scale (HADS). Anxiety score. Timepoint: At the beginning of the study and one month after the intervention. Method of measurement: Based on the Hospital Anxiety and Depression Scale (HADS). Quality of life score. Timepoint: At the beginning of the study and one month after the intervention. Method of measurement: Based on the Headache Impact Test (HIT) questionnaire. Esfahan University of Medical Sciences Approved 2021-08-02 Ethics committee of Esfahan university of Medical sciences No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)