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IRCT20231114060051N1 IRCT 2023-11-25 Bagheiat-allah University of Medical Sciences The effectiveness of brain stimulation on post-traumatic stress disorder (PTSD) The effectiveness of bilateral transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (dlPFC) on attentional and memory bias and dissociative reactions in patients with post-traumatic stress disorder (PTSD) 2023-12-11 anticipated 40 Complete https://irct.ir/trial/73737 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Convenience sampling will be conducted, however, we will allocate participants randomly to one of experiment or control groups using statistical softwares, Blinding description: The control group will be undergoing sham stimulation in which the electrode position will be the same as that used for real stimulation; however, the current will ramp up and ramp down at the early seconds of the beginning and end of the session without participants’ awareness. N/A Post-traumatic stress disorder (PTSD). Intervention 1: Intervention group: The participants of the intervention group will be undergoing electrical stimulation. The target brain areas for stimulation will be the left and right dorsolateral prefrontal cortices (F3 and F4 according to the international 10-20 system, respectively), which will be target of anodal and cathodal stimulation, respectively. The duration of each session will be 20 minutes and the current intensity will be 2 mA. The number of sessions will be 10 during 5 consecutive days. The size of the electrodes will be 30 square centimeters. Intervention 2: Control group: The control group will be undergoing sham stimulation in which the electrode position will be the same as that used for real stimulation; however, the current will ramp up and ramp down at the early seconds of the beginning and end of the session without participants’ awareness. Yes - There is a plan to make this available What will be shared: The data file of the participants in a non-identifiable form, the study protocol, the informed consent form, and the clinical study report will be accessible to other researchers and clinicians in the field of mental health after the end of the research and the publication of the article. When: Accessibility will start after the publication of the results. To whom: Researchers and clinicians in the field of mental health Conditions: The data and protocol of this study will be made available for use in other related research and clinical settings. Where to obtain: Dr.Mohammad Javad Ahmadizadeh mjahmadizadeh@yahoo.com Reza Estaji rezaestaji97@gmail.com How to obtain: Researchers and clinicians in the field of mental health can submit their request to receive the protocol and data of the present study by explaining how they are going to use the mentioned items. The data and protocol will be accessible in a period of less than a week. Comments:
public Mohammad Javad Ahmadizadeh
Baqiyatallah University of Medical Sciences., South Sheikh Bahai St., Mollasadra St., Vanak Square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 4341 mjahmadizadeh@yahoo.com Bagheiat-allah University of Medical Sciences scientific Reza Estaji
Shahid Beheshti University., Shahid Shahriari Square., Evin., Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2655 0352 rezaestaji97@gmail.com Shahid Beheshti University Iran (Islamic Republic of) Diagnosed with PTSD by a professional psychiatrist 20 years no limit Male Having a history of epilepsy, seizure, traumatic brain injury, and neurological surgery Having a history of other major psychiatric disorders F43.1 Post-traumatic stress disorder (PTSD) Treatment - Other Treatment - Other Intervention group: The participants of the intervention group will be undergoing electrical stimulation. The target brain areas for stimulation will be the left and right dorsolateral prefrontal cortices (F3 and F4 according to the international 10-20 system, respectively), which will be target of anodal and cathodal stimulation, respectively. The duration of each session will be 20 minutes and the current intensity will be 2 mA. The number of sessions will be 10 during 5 consecutive days. The size of the electrodes will be 30 square centimeters. Control group: The control group will be undergoing sham stimulation in which the electrode position will be the same as that used for real stimulation; however, the current will ramp up and ramp down at the early seconds of the beginning and end of the session without participants’ awareness. Attention bias: Attention bias and selective attention to negative and trauma-related stimuli. Timepoint: Before intervention, Right after intervention, one month after intervention. Method of measurement: The accuracy and speed of responses in the dot probe and Stroop tasks will be an index of attention bias in the present study. Memory bias: the preference of the memory to recognize and recall negative and trauma-related information. Timepoint: Before intervention, Right after intervention, one month after intervention. Method of measurement: Autobiographical memory test. Dissociative reactions (flashbacks): One of the symptoms of post-traumatic stress disorder in which the patient acts as if they are re-experiencing the traumatic event. Timepoint: Before intervention, Right after intervention, one month after intervention. Method of measurement: Participants' score in the intrusion symptoms subscale (flashbacks) of the PCL-5 rating scale. Bagheiat-allah University of Medical Sciences Approved 2023-10-30 Ethics committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences., South Sheikh Bahai St., Mollasadra St., Vanak Square Tehran Tehran Iran (Islamic Republic of)