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IRCT20180522039775N1 IRCT 2018-10-20 Vice Chancellor for Research, Baqiyatallah University of Medical Sciences Effectiveness of transcranial direct current stimulation in treatment post-traumatic stress disorder Comparison of the effectiveness of transcranial direct current stimulation (tDCS) and eye movement desensitization and reprocessing (EMDR) on post-traumatic stress disorder symptoms (PTSD) 2018-01-29 anticipated 60 Complete https://irct.ir/trial/31383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After determining the sample size (60 people), by random allocation rule, 20 patients were assigned to the intervention group 1, 20 to the intervention group 2 and 20 to the control group. For this purpose, 20 balls for the intervention group 1, 20 balls for the intervention group 2 and 20 balls for the control group are placed inside the lottery container, and then the balls are removed from the container without randomize replacement and the resulting sequence is recorded, Blinding description: In this study, participants, researchers, caregivers, and evaluators are blind. The initial stimulation and appearance of the tDCS device for the target group and the placebo group are quite similar. In the placebo group, after initial stimulation, the tDCS device turns off without notice to the patient, and the device is turned on at the end of the stimulation. Furthermore, patients refer to the clinic at a 90-minute interval in order to reduce the possibility of infiltration of information between them. The researcher is also unaware of the grouping of participants because the allocation of individuals to groups and the referral to the caregiver is done by a statistician. Also, the implementation and evaluation of the outcome is done by a separate individual Caregiver and assessing the outcome of the proposal, hypothesis, and type of patients are unaware. Furthermore, in this study, the placebo group also receives a special type of stimulation (primary and secondary), which makes it makes it difficult to diagnose the target group from the placebo for caregivers and evaluators. In other words, the placebo group does not end the treatment sessions without stimulation. Therefore, the identification of the placebo and target group is difficult. N/A Post-traumatic stress disorder (PTSD). Intervention 1: Intervention group 1: In this group, direct current stimulation was delivered from a battery-driven (Neurosoft, Russia), constant current stimulator and transferred by a pair of 5×7 (35cm2) electrodes. Electrodes were standard carbonic, covered with a normal saline socked sponge cases. In this study, intervention group 1 received real transcranial direct current stimulation (tDCS). In this case, based on the 10-20 system the cathode electrode was placed on right dorsolateral prefrontal cortex (rdLPFC) and anode electrode was placed on the left dorsolateral prefrontal cortex (ldLPFC). 2 mA current for 20 minutes was passed from patient's brain at 10 session. Intervention 2: Intervention group 2: In this group, eye movement desensitization and reprocessing (EMDR) is applied during 45minutes in 5 sessions. For this purpose, EMDR is performed in eight steps: Patient history and treatment planning, preparation, assessment, desensitization, Installation, body scan, clousr and reevaluation. Intervention 3: control group: This group received sham transcranial direct current stimulation (tDCS). For sham stimulation, the same methods of placing anode and cathode were used, however, the stimulator was ramped-up to 2 mA in 30s, then gradually ramped-down to 0 mA over the period of 1 minute, and then turned off. The electrodes were on the scalp for 20 minutes and subjects were not informed that the device is turned off. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: Start the access period 7 months after publishing the results To whom: Data will be available to researchers working in universities and academic institutions Conditions: for scientific use only Where to obtain: Mehdi Rezaei- Tel: 00989383354916- E-mail: Rezaee.mehdi15@yahoo.com How to obtain: The applicant will receive the data within a maximum of one week by explaining the reason for requesting Comments:
public Mehdi Rezaei
Behavioral Science Research Center, Baqiyatallah University of Medical Sciences, Molla-Sadra Sreet, Vanak Sq
Tehran Iran (Islamic Republic of) 3766152624 +98 21 5675 9071 Rezaee.mehdi15@yahoo.com Bagheiat-allah University of Medical Sciences scientific Mehdi Rezaei
Behavioral Science Research Center, Baqiyatallah University of Medical Sciences, Molla-Sadra Sreet, Vanak Sq
Baharestan Iran (Islamic Republic of) 3766152624 +98 21 5675 9071 Rezaee.mehdi15@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age of 18 to 60 years Sign the informed consent form Post-traumatic stress disorder Having a PTSD checklist version (PCL-5) greater than 50 Experienced no change in psychosocial treatments for 2 months before tDCS Experienced no change in psychotropic medication 18 years 60 years Both Axis 1 psychiatric disorders or personality disorders. A history of a significant neurological or medical disorder such as seizure, brain tumors, traumatic brain injury , stroke, Parkinson’s disease, dementia, Huntington’s chorea, multiple sclerosis Changed medications in the 8 weeks prior to commencement of the trial Implanted medication pumps of any sort that would increase the risk of tDCS The risk of Seizure with any reasons, high Intracranial pressure, The history of epilepsy or Seizure in the first relatives, any metal in Head, brain trauma, history of loss of consciousness for more than 5 minutes Pregnancy, breastfeeding High risk of Suicide F43.1 Post-traumatic stress disorder (PTSD) Treatment - Devices Behavior Treatment - Devices Intervention group 1: In this group, direct current stimulation was delivered from a battery-driven (Neurosoft, Russia), constant current stimulator and transferred by a pair of 5×7 (35cm2) electrodes. Electrodes were standard carbonic, covered with a normal saline socked sponge cases. In this study, intervention group 1 received real transcranial direct current stimulation (tDCS). In this case, based on the 10-20 system the cathode electrode was placed on right dorsolateral prefrontal cortex (rdLPFC) and anode electrode was placed on the left dorsolateral prefrontal cortex (ldLPFC). 2 mA current for 20 minutes was passed from patient's brain at 10 session. Intervention group 2: In this group, eye movement desensitization and reprocessing (EMDR) is applied during 45minutes in 5 sessions. For this purpose, EMDR is performed in eight steps: Patient history and treatment planning, preparation, assessment, desensitization, Installation, body scan, clousr and reevaluation control group: This group received sham transcranial direct current stimulation (tDCS). For sham stimulation, the same methods of placing anode and cathode were used, however, the stimulator was ramped-up to 2 mA in 30s, then gradually ramped-down to 0 mA over the period of 1 minute, and then turned off. The electrodes were on the scalp for 20 minutes and subjects were not informed that the device is turned off. Score of PTSD on post-traumatic stress index (PCL-5). Timepoint: Before intervention, Final session, one month after intervention. Method of measurement: Post-traumatic stress index (PCL-5). Score of anxiety. Timepoint: Before intervention, final session ,one month after intervention. Method of measurement: Beck Anxiety Inventory. Score of depression. Timepoint: Before intervention, final session ,one month after intervention. Method of measurement: Beck Depression Inventory (BDI-II). Score of rumination. Timepoint: Before intervention, final session ,one month after intervention. Method of measurement: Ruminative Response Scale (RRS). Vice Chancellor for Research, Baqiyatallah University of Medical Sciences Approved 2017-12-11 Ethics committee of Baqiyatallah University of Medical Sciences Behavioral Science Research Center, Baqiyatallah University of Medical Sciences, Sheykh Bahaei Ave, Molla Sadra Ave, Vanak square Tehran Tehran Iran (Islamic Republic of)