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Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Patients With Treatment Non-Response Obsessive-Compulsive Disorder

Protocol summary

Study aim
Determining the therapeutic effect of recurrent transcranial magnetic stimulation of the brain with a frequency of 1 Hz and LDLPFC target in patients with obsessive-compulsive disorder without response to drug therapy
Design
Clinical trial with control group, double-blind, randomized phase 2-3 on 32 patients. Random number table was used for randomization.
Settings and conduct
A double-blind clinical trial on patients with obsessive-compulsive disorder without response to treatment among outpatients admitted to Shahid Beheshti Hospital. Blindness is based on a random number table, and the therapist and patient are unaware of those who are blind. The study is performed in two groups and 16 patients in each group. The first group will receive effective nausea and the second group ineffective mobility, and the Yale Brown, Hamilton Anxiety, and Depression Questionnaires will be completed three times, the day before hospitalization, the day after treatment, and three months later during the interview.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 18 years of age and right-handed with a diagnosis of moderate to high OCD on the YBOCS scale who have not responded to at least two first-line drugs despite a sufficient dose and 12-week course of treatment Exclusion criteria: Comorbidity with other psychiatric disorders except major depressive disorder, seizures, pregnancy, unstable medical conditions, cerebral metal implants, pacemaker, inner ear prosthesis
Intervention groups
The first group will receive 1 Hz stimulation on the lateral dorsal lateral cortex (L-DLPFC) and the second group will receive ineffective stimulation on the same area. They will receive 20 sessions twice a week and 3 times a week.
Main outcome variables
Symptoms of obsessive-compulsive disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210818052221N1
Registration date: 2021-10-18, 1400/07/26
Registration timing: prospective

Last update: 2021-10-18, 1400/07/26
Update count: 0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Javad Ghiami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4001
Email address
ghiami.javad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Patients With Treatment Non-Response Obsessive-Compulsive Disorder
Public title
Effectiveness of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All persons over 18 years of age and right-handed who have complete diagnostic criteria for obsessive-compulsive disorder based on the diagnostic and statistical manual of mental disorders According to the standard Yale-Brown scale, the diagnosis of obsessive-compulsive disorder is moderate to high At least two first-line drugs for the treatment of obsessive-compulsive disorder have not responded despite a sufficient dose and 12-week course of treatment.
Exclusion criteria:
Simultaneous onset of other psychiatric disorders based on diagnostic and statistical manual of mental disorders except major depressive disorder Seizures, pregnancy, unstable medical conditions Brain metal implants, pacemaker, inner ear prosthesis
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 32
More than 1 sample in each individual
Number of samples in each individual: 3
.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the study will be done with the help of a table of random numbers. Random number table is a set of numbers that is produced without a specific pattern or order and in a completely random way and has become a table. The pattern of reading the numbers from left to right will be determined and then the extracted even numbers will be assigned to the intervention group and the odd numbers will be assigned to the control group. This process will continue to reach the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind and each patient receives a code and both rTMS and SHAM are performed by an rTMS specialist. The main collaborators of the project and the patients and all of them are 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 Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square,
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2020-12-05, 1399/09/15
Ethics committee reference number
IR.ZUMS.REC.1399.312

Health conditions studied

1

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
Obsessive-compulsive score in the Yale-Brown questionnaire
Timepoint
Completion of the questionnaire of patients in both groups in three shifts, one day before the start of rTMS treatment, one day after the completion of the treatment period and after the quarterly follow-up
Method of measurement
Yale-Brown Questionnaire

Secondary outcomes

1

Description
Anxiety score
Timepoint
Completion of the questionnaire of patients in both groups in three shifts, one day before the start of rTMS treatment, one day after the completion of the treatment period and after the quarterly follow-up
Method of measurement
Hamilton Anxiety Questionnaire (HAM-A)

2

Description
Depression score
Timepoint
Completion of the questionnaire of patients in both groups in three shifts, one day before the start of rTMS treatment, one day after the completion of the treatment period and after the quarterly follow-up
Method of measurement
Hamilton Depression Questionnaire

Intervention groups

1

Description
Intervention group: A 1 Hz repetitive transcranial magnetic field will be performed on the lateral dorsal side of the left frontal cortex (L-DLPFC) for 20 sessions 3 times per week. In total, each intervention will last one month.
Category
Treatment - Devices

2

Description
Control group: Control group: Ineffective repetitive transcranial magnetic stimulation on the lateral dorsal side of the left frontal cortex (L-DLPFC) in 20 sessions 3 times per week. In total, each intervention will last one month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Javad Ghiami
Street address
Shahid Beheshti Hospital, Arg Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
ghiami.javad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Boulevard
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mina Shaabani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Arg Square
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۶۱۵۷۸۸
Phone
+98 24 3354 4001
Email
manaz@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Javad Ghiami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Arg Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
ghiami.javad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Javad Ghiami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Arg Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
ghiami.javad@gmail.com

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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