The effect of Repetitive transcranial magnetic stimulation (r-TMS) in the supplementary motor area (SMA) on the symptoms of patients with obsessive-compulsive disorder
Determining the effect of repeated transcranial magnetic stimulation in the supplementary motor area on the symptoms of obsessive-compulsive disorder patients referred to Shahid Beheshti Hospital, Kerman.
Design
randomized double-blind study, with parallel groups and with 40 patients
Settings and conduct
During 4 weeks, treatment with magnetic stimulation of the brain with Standard Rapid2 rTMS device (Magstim company) as follows: Inhibitory right and left SMA in one session (1500 pulses for each side), Orientation 180 degrees • 12 sessions, 3 times a week • Sham coil group, tilted • Both groups have drug treatment.
Participants/Inclusion and exclusion criteria
The statistical population of this research is all people with a definite diagnosis of OCD referring to Shahid Beheshti hospital clinic.
Intervention groups
OCD patients will be randomly divided into two intervention groups (Medical therapy + RTMS) and control group (Medical therapy).
Main outcome variables
Duration of infection and type of obsession (contamination, symmetry, aggression, religious and sexual, morbid doubt) and clinical symptoms - severity of obsessive-compulsive disorder - quality of life - depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230508058129N1
Registration date:2023-05-12, 1402/02/22
Registration timing:prospective
Last update:2023-05-12, 1402/02/22
Update count:0
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Farzane Fadaie Kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5700
Email address
farzanefadaiekermani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Repetitive transcranial magnetic stimulation (r-TMS) in the supplementary motor area (SMA) on the symptoms of patients with obsessive-compulsive disorder
Public title
The effect of Repetitive transcranial magnetic stimulation (r-TMS) in the supplementary motor area (SMA) on the symptoms of patients with obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of OCD based on the DSM V diagnostic criteria by two psychiatrists (clinical interview)
obtaining a score equal to or greater than 16 from the Y-BOCS questionnaire,
not taking related drugs in the last four weeks and starting drug treatment with sertraline 150 mg (simultaneously to along with r-TMS for the intervention group),
not receiving ECT in the past 6 months and the willingness of the subjects to participate in the research
Exclusion criteria:
Existence of accompanying psychiatric disorder, especially depression (based on Beck Depression Scale) score of Beck Questionnaire above 10, suffering from seizures
use of drugs and substances, presence of metal implants, pacemaker, trauma or head injury and neurosurgery procedures
incompleteness of patients data more than 10%
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is available sampling method from eligible patients. Sampling will be done until reaching the desired sample size, and then the patients will be entered into two intervention and control groups based on replacement blocks. Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2.
Blinding (investigator's opinion)
Double blinded
Blinding description
Grouping of patients will be done based on random sampling and in 2 groups A and B. Both groups will be exposed to similar interventions; with the difference that the control group will only be subjected to the standard drug regimen and Sham will be used for them; So that the device will be placed on the patient's scalp without magnetic stimulation. The patients and the statistical analyst were not aware of the treatment method in detail and only knew of their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Scineces
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.KMU.REC.1401.315
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
Yale-Brown Obsession Scale
Timepoint
Before the start of the study, after each RTMS session, 3 months after the last session
Method of measurement
Using a standard questionnaire
Secondary outcomes
1
Description
Quality of Life Brief Version (WHOQOL-BREF)
Timepoint
Before the intervention, after each session, 3 months after the last session
Method of measurement
Based on a standard questionnaire
2
Description
Symptoms of obsession
Timepoint
Before the intervention, after each session, 3 months after the last session
Method of measurement
Based on a standard questionnaire
3
Description
Beck depression questionnaire 2
Timepoint
Before the intervention, after each session, 3 months after the last session
Method of measurement
Based on a standard questionnaire
Intervention groups
1
Description
Intervention group: standard drug treatment + treatment using magnetic stimulation of the brain with rTMS device - during 4 weeks treated with magnetic stimulation of the brain with rTMS device model Standard Rapid2 (Magstim company) is as follows: Right and left SMA inhibition in one Session (1500 pulses for each side), Orientation 180 degree, 12 sessions 3 times a week + standard drug treatment which is sertraline.
Category
Treatment - Devices
2
Description
Control group: only standard medical treatment of the disease - this group will not be subjected to rTMS intervention and the device will be placed on their scalp without magnetic stimulation + standard medical treatment which is sertraline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital Clinic, Kerman
Full name of responsible person
Farzane Fadaei Kermani
Street address
Kerman - Islamic Republic Blvd - 27 Alley
City
Kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3211 0408
Fax
+98 34 3211 6330
Email
farzanefadaiekermani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abedin Iranpour (Deputy for Research and Technology)
Street address
Kerman - Islamic Republic Blvd - 27 Alley
City
Kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3211 0408
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Farzane Fadaie Kermani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7618833639
Phone
+98 34 3132 5700
Fax
Email
Farzanefadaiekermani@gmail.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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Start access when the article is published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The researcher will be available for further analysis and review studies upon request to ensure the accuracy of the data.
From where data/document is obtainable
Researcher responsible for the project - email address: pdivsalar@yahoo.com, contact number: +98 34 1211 6328, postal address: 7618834115
What processes are involved for a request to access data/document
In case of contacting the researcher responsible for the project and confirming the identity of the people, the data will be provided to them within 1 week.