Assessment of the effect of repetitive transcranial magnetic stimulation on right supplementary motor area in patients with Obsessive-Compulsive disorder by Event Related Potential
Assessment of the therapeutic effect of repetitive transcranial magnetic stimulation in obsessive compulsive patients.
Design
Among all the patients referred to psychiatry clinics of public hospitals and private services, 12 patients who have the criteria of obsessive compulsive disorder based on interview and achieve the score of 16 or more in Yale Brown testand fulfill the inclusion criteria are selected. All the participants get the same intervention of transcranial magnetic stimulation.
Settings and conduct
Before and after treatment intervention all the participants take the event related potential and psychological tests including Yale Brown and Beck depression and anxiety tests. Then the patients take 20 sessions of repetitive transcranial magnetic stimulation. Follow up tests will be taken.
Participants/Inclusion and exclusion criteria
The main inclusin criteria: diagnosis of obsessive compulsive disorder and getting at least 16 score in Yale brown test despite a period of treatment.
The main exclusion criteria: history of seizure. external metal material in body. being left handed and pregnant.
Intervention groups
20 sessions of repetitive transcranial magnetic stimulation on the right Supplementary Motor Area for all participants.
Main outcome variables
Repetitive transcranial magnetic stimulation could be an appropriate non invasive augmentation therapy suggested to OCD patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170309032972N2
Registration date:2018-05-20, 1397/02/30
Registration timing:retrospective
Last update:2018-05-20, 1397/02/30
Update count:0
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
afsaneh Mohammadzadeh
Name of organization / entity
assistant of psychiatry at MUMS
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 4506
Email address
mohammadzadeha931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
research unit of Mashhad university medical sciences
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of repetitive transcranial magnetic stimulation on right supplementary motor area in patients with Obsessive-Compulsive disorder by Event Related Potential
Public title
rTMS in OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of obsessive compulsive disorder through psychiatric interview based on DSM 5 criteria and getting at least score 16 in Yale Brown Test
recent use of an OCD treatment for at least 8 to 12 weaks with enough dosage and lack of appropriate response
being right handed
deliberate consent to participate in the study
Exclusion criteria:
suffering from any other major psychiatric disorder including Anxiety, depressive and psychotic disorders.
suffering from any sever organic disorder
history of any kind of seizure in the patient or his family
using medications affecting electroencephalographic waves
having implanted pace maker
having fixed or portable metal prosthesis in the head, neck, chest or arm
having arterial clipper
being pregnant
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee in medical researches
Street address
Mashhad University of Medical Sciences Administration Center(Qoreishi Building), Daneshgah St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.MUMS.fm.REC.1395.466
Health conditions studied
1
Description of health condition studied
obssessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
The essential feature is recurrent obsessional thoughts or compulsive acts. Obsessional thoughts are ideas, images, or impulses that enter the patient's mind again and again in a stereotyped form. They are almost invariably distressing and the patient oft
Primary outcomes
1
Description
parameters of Event Related Potential
Timepoint
before and after intervention
Method of measurement
analysis of the data by the expert
Secondary outcomes
1
Description
obsessive compulsive symptoms
Timepoint
before and after the intervention - after the tenth session - 6 and 12 weeks after the intervention
Method of measurement
Yale Brown Test
2
Description
depression symptoms
Timepoint
before and after the intervention - after the tenth session - 6 and 12 weeks after the intervention
Method of measurement
Beck Depression Inventory
3
Description
anxiety symptoms
Timepoint
before and after the intervention - after the tenth session - 6 and 12 weeks after the intervention
Method of measurement
Beck Anxiety Inventory
Intervention groups
1
Description
1- Event related Potential:
before and after intervention of rTMS
An event-related potential (ERP) is the measured brain response that is the direct result of a specific sensory, cognitive, or motor event. It is a stereotyped electrophysiologica
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry clinic
Full name of responsible person
Afsaneh Mohammadzadeh
Street address
Ibn-e-Sina Hospital Bou ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
91858-95678
Email
afsane_mz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences Research Center
Full name of responsible person
Dr Mir Heydari
Street address
Mashhad University of Medical Sciences Research Center,Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91858-95678
Phone
+98 51 3711 2701
Email
afsane_mz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences Research Center
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
Psychiatry and Behavioral Sciences Research Center Mashhad University of Medical Sciences Mash
Full name of responsible person
Afsaneh Mohammadzadeh
Position
Psychiatry assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina Hospital, Bou Ali square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91858-95678
Phone
+98 51 3711 2701
Fax
Email
afsane_mz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatry departmant Mashhad University of Medical Sciences Mashhad Iran
Full name of responsible person
Dr Farzad Akbarzadeh
Position
Assisstant proffessor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina hospital, Bou Ali square, Mashhad
City
Masshad
Province
Razavi Khorasan
Postal code
91858-95678
Phone
+98 51 3711 2701
Fax
Email
Akbarzadehf@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center Mashhad University of Medical Sciences Mash
Full name of responsible person
Afsaneh Mohammadzadeh
Position
psychiatry assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn-Sina hospital, Bou Ali square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91858-95678
Phone
+94 5137112701
Fax
Email
mohammadzadeha931@mums.ac.ir
Web page address
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