Evaluation of the effects of low-frequency pulsed magnetic field adjuvant therapy in patients with obsessive-compulsive disorder
Design
randomized double-blind clinical trial
Settings and conduct
This research is a double-blind clinical trial study on 30 patients with obsessive-compulsive disorder in 2024 in Taleghani and Imam Hossein hospitals in Tehran.
Participants/Inclusion and exclusion criteria
Consent to participate in the study
Primary diagnosis of OCD based on the criteria of Diagnostic and Statistical Manual of Mental Disorders, 5th edition
At least moderate intensity based on the obsessive-compulsive scale (YBOCS; score ≥20)
18 to 60 years
Intervention groups
Patients with an initial diagnosis of OCD and suffering from OCD symptoms of at least moderate severity based on the obsessive compulsive scale (YBOCS; score ≥16) were included in the study into two intervention and control groups based on the rule of random assignment (by lottery and without replacement and in considering the sequence) are divided. The LFMPF method is performed using a Transcranial magnetic stimulator. Stimulation parameters in the intervention group for 3 weeks are performed as follows: frequency 10, 15, 20 Hz and intensity 0.1 to 0.4 milliTesla, for 30 minutes (1200 pulses per day) at 100% of the rest movement threshold, once daily, 3 days a week for 3 weeks.
Main outcome variables
Determining the effects of low-frequency pulsed magnetic field auxiliary treatment in patients with obsessive-compulsive disorder can lead to the use of this method to increase the probability of success in treating patients with this disorder by increasing the Yale Brown Obsessive Compulsive Scale (YBOCS) score and Hamilton score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230910059393N1
Registration date:2024-09-11, 1403/06/21
Registration timing:prospective
Last update:2024-09-11, 1403/06/21
Update count:0
Registration date
2024-09-11, 1403/06/21
Registrant information
Name
Zohre Rajabizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 8580
Email address
zohre.rajabizade.1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of low-frequency pulsed magnetic field adjuvant therapy in patients with obsessive-compulsive disorder (OCD)
Public title
investigation the effectiveness of low-frequency pulsed magnetic field in the treatment of obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
consent to participate in the study
18 to 60 years
at least moderate intensity based on the obsessive compulsive scale
initial diagnosis of OCD based on diagnostic and statistical guidelines for mental disorder.fifth edition
Exclusion criteria:
history of epilepsy
drug abuse
significant head injury or any neurosurgery
metal implants and pacemakers
those who received an electrical shock in the last 6 months
people with co-occurring psychiatric disorder other than depression
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients entering the study are divided into two groups based on the random allocation law (by lottery and without replacement and considering the sequence). The study will be conducted as a single-blind study so that the patients will be completely unaware of the nature of the adjuvant treatment and how the groups will be randomized.
Blinding (investigator's opinion)
Double blinded
Blinding description
the blinding of the study will be done bilaterally/so that the patients will be completely unaware of the nature of the adjuvant treatment and how the groups will be randomized. considering that this is an auxiliary treatment and treatment must be done correctly.the doctor dose not know the patient's condition and the doctor is also blinded
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Medicine, Shahid Beheshti University of Medical Sciences, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.SBMU.MSP.REC.1403.020
Health conditions studied
1
Description of health condition studied
obsessive-compulsive disorder (OCD)
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Yale Brown Obsessive Compulsive Scale Score (YBOCS)
Timepoint
30 days after the last round of interventions
Method of measurement
Interviewing the patient and performing the Yale Brown Obsessive-Practice Scale (YBOCS) test
Secondary outcomes
1
Description
Hamilton Depression Rating Scale Score
Timepoint
30 days after the last round of interventions
Method of measurement
Interviewing the patient and performing Hamilton Test
Intervention groups
1
Description
Intervention group: In addition to the treatment according to the protocol of the reference book by therapy sessions and drug therapy, the low-frequency pulsed magnetic field (LFMPF) method is performed using a Transcranial magnetic stimulator. Stimulation parameters in the intervention group for 3 weeks are performed as follows: frequency 10, 15, 20 Hz, with an intensity of 0.1 to 0.4 milliTesla and for 30 minutes (1200 pulses per day) at 100% of the rest movement threshold, once in day, 3 days a week
Category
Treatment - Other
2
Description
Control group: Patients will be treated according to the protocol of the reference book and in the form of therapy sessions and drugs.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kheradmand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleqani Hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 230311
Fax
Email
dr.alikheradmand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kheradmand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleqani Hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 230311
Fax
Email
dr.alikheradmand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Rajabizade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
NO6,Zomorrod alley , North Karegar Avn
City
Tehran
Province
Tehran
Postal code
198571151
Phone
+98 21 4464 8580
Fax
Email
zohre.rajabizade.1991@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identification.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Access to the data will be free for all researchers in the field of psychiatry and psychology.
Under which criteria data/document could be used
Only the obligation to cite the source is required and there are no other conditions
From where data/document is obtainable
The data of this research can be made available after request by e-mail.
What processes are involved for a request to access data/document
The applicant may access the data after one month by stating the purpose and reason for the need for the data documented in this research, if there is no interference with the above-mentioned criteria.