Title: Clinical trial of efficacy of Trans cranial direct current stimulation (TDCS) in reducing post-traumatic stress signs in military post-traumatic stress disorder
The aim of this study was designed to evaluate the effect of treatment with brain electric stimulation on the symptoms of military post traumatic stress disorder patients as a double blind clinical trial.
Design
This study will be designed as a double blind clinical trial In the third phase.The target population of this study will be 60 patients with post traumatic stress disorder who referred to the Toloo Specialist Clinic in Rash.
Settings and conduct
The target population of this study will be 60 patients with post traumatic stress disorder who referred to the Toloo Specialist Clinic in Rash. Patients will be selected by a psychiatrist based on clinical interviews.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with military post traumatic stress disorder; Age: 18 to 60 years; Non-inclusion criteria: existence of any neurological condition; low IQ; unwillingness to participate in the study
Intervention groups
Intervention group1: During treatment straight and uniform Electrical current will be sent to the brain through cathodal type waves for up to 30 minutes. Then this group will be entered into the Sham program for 12 session. Sham program will get electrical stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off.
Intervention group2: In the first 12 sessions will be entered into the Sham program.
Control group: will not have an electrical stimulation (TDCS) of the brain.
Main outcome variables
Symptoms Post-traumatic Stress Disorder
General information
Reason for update
Acronym
TDCS
IRCT registration information
IRCT registration number:IRCT20150427021965N9
Registration date:2018-06-08, 1397/03/18
Registration timing:retrospective
Last update:2018-06-08, 1397/03/18
Update count:0
Registration date
2018-06-08, 1397/03/18
Registrant information
Name
Homa Zarrabi
Name of organization / entity
Guilan University of Medical Sceinces,«Kavosh » Cognitive Behaviour Sciences and Addiction Researc
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
shafakavosh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-10, 1396/11/21
Expected recruitment end date
2018-02-10, 1396/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title: Clinical trial of efficacy of Trans cranial direct current stimulation (TDCS) in reducing post-traumatic stress signs in military post-traumatic stress disorder
Public title
Title: Clinical trial of efficacy of Trans cranial direct current stimulation (TDCS) in reducing post-traumatic stress signs in military post-traumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with military post traumatic stress disorder
Age 18 to 60 years
Exclusion criteria:
existence of any neurological condition
low IQ
Any metal implants or instruments inside the patient’s skull or brain
Any side effect due to treatment intervention
unwillingness to participate in the study
substances- dependency to stimulants in past 6 month
patient have bipolar disorder or psychotic disorder
exacerbation of patient symptoms that need any emergency intervention or elevate in drug dose .
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After convenience sampling, Participants will be assigned to three groups of 20 people using closed envelopes with blocked randomization method. Blocking will be used to create the number of samples assigned to each treatment group. In this study, people will be divided into 10 blocks of 6.
Blinding (investigator's opinion)
Double blinded
Blinding description
For elimination of the possibility of any bias due to the knowledge of patients or physicians evaluation of the results, and possible impact on the outcomes of research a double blind study will be performed, Participants and the evaluating investigators (except the technician that applied TDCS)
will be blind to the intervention type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of vice chancellor Research and Technology, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4193893345
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.GUMS.REC.1396.422
Health conditions studied
1
Description of health condition studied
post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD):rises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in alm
Primary outcomes
1
Description
Depression Score in the Beck's Questionnaire
Timepoint
The effectiveness of the treatment will be evaluated in the twelve, twenty-four, and one-month follow-up sessions.
Method of measurement
The effectiveness of the treatment will be evaluated based on the score obtained from the Beck Depression questionnaire.
2
Description
Anxiety Score in Beck's Questionnaire
Timepoint
The effectiveness of the treatment will be evaluated in the twelve, twenty-four, and one-month follow-up sessions.
Method of measurement
The effectiveness of the treatment will be evaluated based on the score obtained from the Beck Anxiety questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: During treatment straight and uniform Electrical current will be sent to the brain through Cathodal type waves for up to 30 minutes. Then this group will be entered into the Sham group for 12 session. Sham group will get electrical stimulation Tran cranial direct current stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off.
Category
Treatment - Other
2
Description
Intervention group2: Intervention group2: . Sham group will get electrical stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off. In the 12 second days the treatment will be carried out in 12 consecutive sessions and straight and uniform Electrical current will be sent to the brain through Cathodal type waves for up to 30 minutes.
Category
Treatment - Other
3
Description
Control group:Group will not have an electrical stimulation (TDCS) of the brain.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooloo Specialty and Subspecialty of Psychiatry Clinic of Rasht
Full name of responsible person
Dr Kiomars Najafi
Street address
Shabnam Alley, Golsar Crossroads, Opposite to the Municipal of Area (3),Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
Kkiomars@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mirsaeed Attarchi
Street address
Namjoo Street, University Of Medical Sceinces Guilan,Vice Chancellor for Research, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
93345-41938
Phone
+98 13 3336 2772
Email
msattarchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Kiomars Najafi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
15 khordad Avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
Kkiomars@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Kiomars Najafi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
15 khordad Avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
Kkiomars@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Aida yahyazadeh
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
15 Kordad Avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3311 3995
Email
aidayahyazadeh@yahoo.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be available to researchers through contact with the designer's email.
When the data will become available and for how long
After publishing the article and analyzing the data
To whom data/document is available
After publishing the article and analyzing the data
Under which criteria data/document could be used
Only non-analyzed data will be available to researchers.
From where data/document is obtainable
DR Kiomars Najafi, Tooloo Specialty and subspecialty psychiatry Clinic, Rasht, Shabnam alley, in front of Area 3 municipslity, Golsar Crossroads, Rasht, Iran.
kkiomars@yahoo.com
What processes are involved for a request to access data/document