Comparison of Treatment with Repetitive Transcranial Magnetic Stimulation Combined with Drug Therapy with Drug Therapy Alone in Post-Traumatic Stress Disorder
Comparison of treatment with Repetitive Transcranial Magnetice Stimulation combined with drug therapy with drug therapy alone in PTSD
Design
The study is a three-blind clinical trial on all patients with PTSD. First, patients complete the Beck Depression Inventory and patients with a score of 17 or lower are included in the study. 30 patients are selected and placed in one of two groups A or B. Group A receives 1 Hz for 20 minutes at a time of 3 weeks and 5 times a week while continuing the drug treatment, and group B patients receive drug treatment and SHAM. At the end of each week, patients fill out the questionnaire again. At the end of the study, the mean scores of the questionnaire in both groups are compared to the beginning of the study and the other group to determine the effectiveness of each treatment regimen independently and in comparison with others, as well as the rate of remission.
Settings and conduct
By multi-stage random sampling, easy random sampling among patients with moderate to severe PTSD referred to the psychiatric clinic of 22 Bahman Hospital in Qazvin
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 60 years old, history of moderate to severe PTSD according to Beck Depression Inventory that do not score above seventeen, Exclusion criteria: having other psychiatric illnesses, history of seizures, history of Drug Abuse, history of neurosurgery complications, having implants
Intervention groups
Group "A" is the intervention group that is treated with rTMS device for 5 days a week (a total of 1,200 pulses / day) for 3 weeks at the same time as taking the drug. While patients in group "B" or the control group are only treated with standard drug regimen and sham is used for them so that the device was placed on their scalp without magnetic stimulation.
Main outcome variables
Severity of post-traumatic stress disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171205037768N2
Registration date:2021-01-16, 1399/10/27
Registration timing:registered_while_recruiting
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Mohsen Zamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 5054
Email address
mzamir@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
2020-08-06, 1399/05/16
Actual recruitment end date
2021-02-23, 1399/12/05
Trial completion date
2021-02-23, 1399/12/05
Scientific title
Comparison of Treatment with Repetitive Transcranial Magnetic Stimulation Combined with Drug Therapy with Drug Therapy Alone in Post-Traumatic Stress Disorder
Public title
Repetitive Transcranial Magnetic Stimulation in Post-Traumatic Stress Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years old
History of PTSD
According to Beck Depression Inventory did not get a score above 17.
At least four weeks (the minimum duration of drug effect) have elapsed since the start of drug treatment
Exclusion criteria:
Accompanied by other mental illnesses including depression
History of epilepsy or seizures
History of Drug Abuse
History of severe head trauma or other severe neurosurgery complications
Having any type of metal implant
Using Pace
Receive any type of electroconvulsive therapy for the past 6 months
Current pregnancy
Receive CBT (cognitive-behavioral therapy) at the same time with the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is three-blind and each patient receives a code and both RTMS and SHAM are performed by one of the nurses. The main collaborators of the project and the patients and the person who finally analyzes the results are all unaware of which patient is in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin university of Medical Sciences
Street address
Qazvin university of medical sience, Shahid Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
14002510
Health conditions studied
1
Description of health condition studied
Post-trumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Post-traumatic stress disorder score based on CAPS questionnaire
Timepoint
Weeks 0, 2, 4 and 8
Method of measurement
CAPS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group or A: Group of patients with post-traumatic stress disorder Simultaneously with taking the drug were treated with r-TMS at a frequency of 1 Hz for 20 minutes with an interval of one day for 15 weeks in 15 sessions.
Category
Treatment - Devices
2
Description
Control group or B: Group of patients with post-traumatic stress disorder who Simultaneously with drug treatment with standard drug regimen were treated with sham for 20 minutes at intervals of one day for three weeks in 15 sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Marjan Mahmoudian
Street address
22 Bahman Hospital, Railway Street, Nurse Alley
City
Qazvin
Province
Qazvin
Postal code
3416899198
Phone
+98 28 3355 5054
Email
Marjanmahmudian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjomeh
Street address
22 Bahman Hospital, Nurse Alley, Railway Street
City
Qazvin
Province
Qazvin
Postal code
3416899198
Phone
+98 28 3355 5054
Email
Marjanmahmudian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?