A Comparative Study of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) at 1 Hz and 0.5 Hz in Improving Symptoms of Patients with Obsessive-Compulsive Disorder
To compare the efficacy of repetitive transcranial magnetic stimulation at 1 and 0.5 hertz in improving symptoms of obsessive compulsive disorder.
Design
Single blind randomized parallel group clinical trial in 80 patients; block randomization.
Settings and conduct
The study will be conducted at Khorshid Hospital in Isfahan; patients will enter after informed consent; the outcome assessor will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years with treatment resistant obsessive compulsive disorder; psychiatrist confirmed diagnosis; non response to pharmacotherapy and cognitive behavioral therapy; non inclusion, uncontrolled psychiatric disorder, epilepsy, neurological disease, major medical illness, contraindication to magnetic stimulation, metallic object in the head or neck, no consent.
Intervention groups
Two active intervention groups; 1 hertz and 0.5 hertz; 10 sessions every other day for 3 weeks.
Main outcome variables
Change in total Yale Brown Obsessive Compulsive Scale score from before to after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053132N4
Registration date:2026-04-15, 1405/01/26
Registration timing:prospective
Last update:2026-04-15, 1405/01/26
Update count:0
Registration date
2026-04-15, 1405/01/26
Registrant information
Name
Ali Shariat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 8307
Email address
alish@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-06-21, 1405/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) at 1 Hz and 0.5 Hz in Improving Symptoms of Patients with Obsessive-Compulsive Disorder
Public title
Comparison of Two Types of Brain Magnetic Stimulation for Improving Symptoms in Patients with Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis of obsessive-compulsive disorder confirmed by a psychiatrist based on DSM-5 criteria
inadequate response to at least two selective serotonin reuptake inhibitors (SSRIs) and clomipramine (each administered for at least 6 weeks),
non-response to cognitive behavioral therapy (CBT).
Exclusion criteria:
uncontrolled psychiatric comorbidities such as major depression or anxiety disorders,
significant active medical conditions,
history of epilepsy or other neurological disorders,
contraindications to transcranial magnetic stimulation (including metallic implants in the head or neck),
unwillingness to participate in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will allocate to the two treatment groups using block randomization with a block size of 2. The possible allocation sequences will be AB and BA. For each block, one sequence will select using a random number table, and participants will assign accordingly in the order of enrollment to ensure balance between groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor (Y-BOCS evaluator) will blind to group allocation. Due to the nature of the intervention,
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-12-01, 1404/09/10
Ethics committee reference number
IR.MUI.MED.REC.1404.353
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
Change in total score of the Yale Brown Obsessive Compulsive Scale
Timepoint
At baseline before the intervention and at the end of the study after completion of the tenth treatment session
Method of measurement
Yale Brown Obsessive Compulsive Scale administered through interview and scored by the evaluator
Secondary outcomes
1
Description
Total score of the Yale Brown Obsessive Compulsive Scale at baseline
Timepoint
At baseline before the intervention
Method of measurement
Yale Brown Obsessive Compulsive Scale administered through interview and scored by the evaluator
2
Description
Total score of the Yale Brown Obsessive Compulsive Scale at the end of the study
Timepoint
At the end of the study after completion of the tenth treatment session
Method of measurement
Yale Brown Obsessive Compulsive Scale administered through interview and scored by the evaluator
Intervention groups
1
Description
Intervention group: Participants in this group receive repetitive transcranial magnetic stimulation at a frequency of 1 hertz. The intervention consists of 10 treatment sessions every other day over 3 weeks. In each session, stimulation is delivered at 100 percent of motor threshold, with 15 trains and 100 pulses per train, using the Super Rapid 2 device, with the coil positioned over the dorsolateral prefrontal cortex.
Category
Treatment - Devices
2
Description
Intervention group: Intervention group: Participants in this group receive repetitive transcranial magnetic stimulation at a frequency of 0.5 hertz. The intervention consists of 10 treatment sessions every other day over 3 weeks. In each session, stimulation is delivered at 100 percent of motor threshold, with 15 trains and 100 pulses per train, using the Super Rapid 2 device, with the coil positioned over the dorsolateral prefrontal cortex.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Ali Shariat
Street address
Khorshid Hospital, Ostandari street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2475
Email
Alish@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building No. 4, Vice Chancellor for Research and Technology, Hezar Jarib Avenue , Isfahan University of Medical Sciences and Health Services,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Building No. 4, Vice Chancellor for Research and Technology, Hezar Jarib Avenue , Isfahan University of Medical Sciences and Health Services,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Building No. 4, Vice Chancellor for Research and Technology, Hezar Jarib Avenue , Isfahan University of Medical Sciences and Health Services,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Shariat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3263 8307
Email
alish@med.mui.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