Protocol summary

Study aim
Evaluation of the effect of high-definition transcranial direct current stimulation with delta wave on clinical symptoms, salivary cortisol and serum BDNF level of patients with Post Traumatic Stressor Disorder(PTSD)
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 40 patients; Simple randomization method is used. To randomize people in groups, the following command code was given in Kotlin programming language. val randomValues ​​= List(40) { Random.nextInt(1, 3) } println(randomValues) Then, the following output was obtained, which includes the random order of entry of people in groups one and two. [1, 2, 2, 2, 1, 2, 1, 2, 2, 2, 1, 1, 2, 1, 1, 1, 2, 2, 1, 1, 1, 2, 2, 1, 2 , 2, 1, 2, 2, 1, 2, 2, 1, 1, 1, 2, 1, 1, 1, 1] Based on this, twenty people are in group one and twenty people are in group two, and for each new person entering, according to this arrangement, people are assigned to group one or two..
Settings and conduct
This trial is A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 40 patients referred to Janat psychiatry hospital of Shiraz or Baghiatollah Hospital of Tehran from August of 2024
Participants/Inclusion and exclusion criteria
Patients referred to the center at the mentioned timeline which have the DSM-5or PCL-5 criteria and have been stable with no recent history of drug abuse in the last 2 weeks and doesn't have any contraindication for HD-tDCS
Intervention groups
Patients are randomly classified into 2 groups of 20, one with sham stimulation and the other with real one
Main outcome variables
Making a protocol for treatment of the patients with PTSD specially for war veterans; Using non aggressive methods like HD-tDCS for their treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171128037666N4
Registration date: 2024-08-11, 1403/05/21
Registration timing: registered_while_recruiting

Last update: 2024-08-11, 1403/05/21
Update count: 0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
Boshra Hatef
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3225 3495
Email address
boshrahatef@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of High-Definition transcranial Direct Current Stimulation with delta wave on clinical symptoms, salivary cortisol and serum BDNF level of patients with Post Traumatic Stressor Disorder(PTSD)
Public title
Effect of High-Definition transcranial Direct Current Stimulation on PTSD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM-5 or PCL-5 criteria Being stable in recent 2 weeks No recent history of drug abuse No contraindication for HD-tDCS
Exclusion criteria:
History of being unstable or Drug abuse in recent 2 weeks Patients with history of cardiac problems who use pace makers Patients with ICDs Patients with scalp lesions
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly diveded into 2 groups of fake or real stimulation, simple randomization method is used.To randomize people in groups, the following command code was given in Kotlin programming language. val randomValues ​​= List(40) { Random.nextInt(1, 3) } println(randomValues) Then, the following output was obtained, which includes the random order of entry of people in groups one and two. [1, 2, 2, 2, 1, 2, 1, 2, 2, 2, 1, 1, 2, 1, 1, 1, 2, 2, 1, 1, 1, 2, 2, 1, 2 , 2, 1, 2, 2, 1, 2, 2, 1, 1, 1, 2, 1, 1, 1, 1] Based on this, twenty people are in group one and twenty people are in group two, and for each new person entering, according to this arrangement, people are assigned to group one or two.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this trial, patients are blinded to the group they are classified into, but they are completely aware of other aspects of the trial. That is, they do not know whether the device is on or off on their head.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baghiatallah University of Medical Sciences
Street address
Mollasadra Ave, Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.068

Health conditions studied

1

Description of health condition studied
PTSD
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
Post-traumatic Stress Disorder Checklist-5 score
Timepoint
Before an after 10 session of treatment
Method of measurement
Medscpae Posttraumatic Stress Disorder Checklist-5 test

Secondary outcomes

1

Description
Salivary Cortisol
Timepoint
Before and after 10 sessions of treatment
Method of measurement
Salivary Cortisol kit available in lab

2

Description
Serum Brain-Derived Neurotropic Factor
Timepoint
Before and after 10 sessions of treatment
Method of measurement
Serum Brain-Derived Neurotropic Factor kit available at lab

Intervention groups

1

Description
Intervention group: Group of patients which are stimulated with HD-tDCS and neuropsychiatric tests and lab tests are taken from them before and after stimulation. 10 sessions of treatment in 2 weeks(excepts Thursdays and Fridays) each for 20 minutes with the setting ofthe device on 2mA and Central electrode at T8 and ring Cathodes at EX10, P8, C4, F8 and biphasic mode with delta wave at 0.4 to 0.5 Hz
Category
Treatment - Devices

2

Description
Control group: Group of patients which are shamely stimulated with HD-tDCS and neuropsychiatric tests and lab tests are taken from them before and after stimulation. 10 sessions of sham treatment is needed in 2 weeks(excepts thursdays and fridays) each for 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Jannat psychiatry hospital
Full name of responsible person
Alireza Asemanrafat
Street address
Ostad Farashbandi Blvd, West side of Jannat garden, Amirkabir Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7178754111
Phone
+98 71 3842 5110
Email
a.asemanrafat@gmail.com

2

Recruitment center
Name of recruitment center
Neuroscience Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Alireza Asemanrafat
Street address
Mollasadra Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
a.asemanrafat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hosein Kachoui
Street address
‌Mollasadra Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5259
Email
R.bmsu@yahoo.com
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
Gila Pirzad Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Mollasadra St, Vanak Sq
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
gpirzad1340@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Boshra Hatef
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Baghiatallah University, Mollasadra Ave, Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Boshra Hatef
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mollasadra Ave, Vanak sq, Tehran
City
Tehran
Province
Tehran
Postal code
881435916471
Phone
+98 21 8804 0060
Email
boshrahatef@bmsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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