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)
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)
Design
This study is a sham-controlled, parallel-group, single-blind, randomized clinical trial including 40 patients with post-traumatic stress disorder (PTSD). The "rand" function of MATLAB software will be used to randomly assign participants.
Settings and conduct
Convenience sampling method will be used to select the participants of the present study. The sample of the current study consists of 40 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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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 and the inter-session interval will be 24 hours. The size of the electrodes will be 35 square centimeters.
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)
Public title
The effectiveness of brain stimulation on post-traumatic stress disorder (PTSD)
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling will be conducted, however, we will allocate participants randomly to one of experiment or control groups using statistical softwares.
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences., South Sheikh Bahai St., Mollasadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.075
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder (PTSD)
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Attention bias: Attention bias and selective attention to negative and trauma-related stimuli.
Timepoint
Before intervention, Right after intervention, Three 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.
2
Description
Memory bias: the preference of the memory to recognize and recall negative and trauma-related information.
Timepoint
Before intervention, Right after intervention, Three month after intervention.
Method of measurement
Autobiographical memory test
3
Description
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, Three month after intervention.
Method of measurement
Participants' score in the intrusion symptoms subscale (flashbacks) of the PCL-5 rating scale.
Secondary outcomes
empty
Intervention groups
1
Description
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 and the inter-session interval will be 24 hours. The size of the electrodes will be 35 square centimeters.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyat Allah Al-Azam Educational-Therapeutic Center
Full name of responsible person
Reza Estaji
Street address
Baqiyat Allah Al-Azam Educational-Therapeutic Center., after Sheikh Bahai St., Mollasadra St., Vanak Square
Baqiyat Allah Al-Azam Educational-Therapeutic Center., after Sheikh Bahai St., Mollasadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8805 0436
Email
msaberi@bmsu.ac.ir
Web page address
https://research.bmsu.ac.ir/portal/home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Javad Ahmadizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Baqiyatallah University of Medical Sciences., South Sheikh Bahai St., Mollasadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4341
Email
mjahmadizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Reza Estaji
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University., Shahid Shahriari Square., Evin., Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2655 0352
Fax
Email
rezaestaji97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Reza Estaji
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University., Shahid Shahriari Square., Evin., Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2655 0352
Fax
Email
rezaestaji97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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 the data will become available and for how long
Accessibility will start after the publication of the results.
To whom data/document is available
Researchers and clinicians in the field of mental health
Under which criteria data/document could be used
The data and protocol of this study will be made available for use in other related research and clinical settings.
What processes are involved for a request to access data/document
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.