Protocol summary
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Study aim
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Investigation the effect 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)
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Design
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This study is a sham-controlled, parallel-group, single-blind, randomized clinical trial including 26 patients with post-traumatic stress disorder (PTSD). The "rand" function of MATLAB software will be used to randomly assign participants.
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Settings and conduct
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Convenience sampling method will be used to select the participants of the present study. The sample of the current study consists of 26 war veterans diagnosed with PTSD and hospitalized in the psychiatric department of Baqiyat Allah Al-Azam Educational-Therapeutic Center located in Tehran. Each patient should complete a consent form before participating in the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Diagnosed with PTSD by a professional psychiatrist
Exclusion criteria:
2. History of epilepsy, seizure, traumatic brain injury, and neurological surgery
3. History of other major psychiatric disorders
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Intervention groups
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Participants will be randomly assigned to two experimental conditions. 1) Receiving real electrical stimulation and psychotropics 2) Receiving sham electrical stimulation and drug therapy. 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 the 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.
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Main outcome variables
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1. Attention bias
2. Memory bias
3. Dissociative reactions
General information
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Reason for update
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Adjusting the number of patients participating in the study due to significant setbacks in identifying suitable candidates meeting the inclusion criteria and able to continue with the study.
Moreover, new information respecting inter-session interval and the follow-up stage of the study was included.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231114060051N1
Registration date:
2023-11-25, 1402/09/04
Registration timing:
registered_while_recruiting
Last update:
2025-01-03, 1403/10/14
Update count:
1
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Registration date
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2023-11-25, 1402/09/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-11, 1402/09/20
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Expected recruitment end date
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2024-04-18, 1403/01/30
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Actual recruitment start date
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2023-11-22, 1402/09/01
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Actual recruitment end date
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2024-05-19, 1403/02/30
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Trial completion date
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2024-05-19, 1403/02/30
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Scientific title
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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)
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Public title
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The effectiveness of brain stimulation on post-traumatic stress disorder (PTSD)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosed with PTSD by a professional psychiatrist
Exclusion criteria:
Having a history of epilepsy, seizure, traumatic brain injury, and neurological surgery
Having a history of other major psychiatric disorders
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Age
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From 20 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
Actual sample size reached:
26
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Convenience sampling will be conducted, however, we will allocate participants randomly to one of experiment or control groups using statistical softwares.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-30, 1402/08/08
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Ethics committee reference number
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IR.BMSU.BAQ.REC.1402.075
Health conditions studied
1
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Description of health condition studied
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Post-traumatic stress disorder (PTSD)
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ICD-10 code
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F43.1
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ICD-10 code description
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Post-traumatic stress disorder (PTSD)
Primary outcomes
1
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Description
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Attention bias: Attention bias and selective attention to negative and trauma-related stimuli.
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Timepoint
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Before intervention, Right after intervention, one month after intervention.
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Method of measurement
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The accuracy and speed of responses in the dot probe and Stroop tasks will be an index of attention bias in the present study.
2
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Description
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Memory bias: the preference of the memory to recognize and recall negative and trauma-related information.
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Timepoint
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Before intervention, Right after intervention, one month after intervention.
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Method of measurement
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Autobiographical memory test
3
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Description
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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.
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Timepoint
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Before intervention, Right after intervention, one month after intervention.
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Method of measurement
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Participants' score in the intrusion symptoms subscale (flashbacks) of the PCL-5 rating scale.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Accessibility will start after the publication of the results.
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To whom data/document is available
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Researchers and clinicians in the field of mental health
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Under which criteria data/document could be used
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The data and protocol of this study will be made available for use in other related research and clinical settings.
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From where data/document is obtainable
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Dr.Mohammad Javad Ahmadizadeh
mjahmadizadeh@yahoo.com
Reza Estaji
rezaestaji97@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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