The objective of this study is to evaluate Efficacy of Repetitive Transcranial Magnetic Stimulation in Treating Refractory Obsessive Compulsive Disorder. Patients hospitalized in Farshchian hospital and out-patients will be selected. After obtaining informed consent, these patients will be randomly allocated to either first receiving " repeatetive transcranial magnetic stimulation (rTMS)" and then "Sham condition " or vice versa. Sham stimulation will be made at the site of active treatment but with only the side edge resting on the scalp. It will be administered as high frequency left( HFL) and high frequency right (HFR) for 50 minutes but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position.after two weeks, Bilateral rTMS will be delivered according to the following protocol: high frequency left (HFL) stimulation will initially be applied at 20 Hz, in 25 trains of 1.5 second duration with a 30 second interval between trains and at 100% of the RMT for a total of Approximately 12.5 minutes of stimulation. Following this HFR stimulation will be applied at the same parameters. Therefore a total of Approximately 25 minutes of stimulation will be delivered.Two groups will be compared regarding symptom severity and illness improvement using YBOCS and CGI measures,in 1st,last and two weeks after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308041743N11
Registration date:2013-11-05, 1392/08/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-05, 1392/08/14
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Repetitive Transcranial Magnetic Stimulation in Treating Refractory Obsessive Compulsive Disorder
Public title
Efficacy of Repetitive Transcranial Magnetic Stimulation in Treating Refractory Obsessive Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
•voluntary and competent to consent based on their ability to provide a spontaneous narrative description of the key elements of the study
•have a Structured Clinical Interview for DSM-IV (SCID) confirmed diagnosis of OCD
•are between the ages of 18 and 65
•have failed to achieve a clinical response, or did not tolerate, at least 3 separate antidepressant trials of sufficient dose (included clomipramine) and CBT for at least 10 weeks
•have a score of greater than or equal to 17 on the Y-BOCS. A careful medical and neurological history will be taken to ensure that subjects have no unstable conditions that would preclude them from entering into the study. This history will focus on conditions such as seizures, neurologic, other medical problems and presence of metal implants
Exclusion Criteria:
•have a history of DSM-IV substance dependence in the last 6 months, and have DSM-IV substance abuse in the last month
•have a concomitant major unstable medical or neurologic illness or have had a history of seizures
•acutely suicidal
•are pregnant
•have metal implants. With respect to concomitant medications, patients will be excluded if they are currently (or in the last 4 weeks) taking: (a) more than lorazepam 2 mg daily (or equivalent), (b) monoamine oxidase inhibitors, (c) and/or bupropion due to its associated increased risk for seizures.
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:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street
City
Hamadan
Postal code
65178/518
Approval date
2013-07-25, 1392/05/03
Ethics committee reference number
1359/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
refractory obsessive compulsive disorder
ICD-10 code
F42.2
ICD-10 code description
Mixed obsessional thoughts and acts
Primary outcomes
1
Description
improvement rate of refractory OCD
Timepoint
after 10th, 20th sessions of rTMS or sham
Method of measurement
CGI و YBOCS
Secondary outcomes
empty
Intervention groups
1
Description
Device: repetitive magnetic stimulation(rTMS) 750 total pulse stimulation at 20 Hz will be delivered with 25 train of 1.5 second duration at 100% of threshold. Bilaterally(right and left) Sham stimulation with coil angled 45-90 degree will applied at the site exactly like rTMS stimulation in total 25 minute.(right and left).This is like true stimulation but have no therapeutic effect
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Mehran Shaygan Fard
Street address
farshchian hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Full name of responsible person
Dr. Mohamad Ahmadpanah
Street address
Farshchian Hospital
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Full name of responsible person
Mehran Shaygan Fard
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
65168-4-8741
Phone
+98 81 1827 4192
Fax
Email
mshayganfard@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr. Mohammad Haghighi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
65168-4-8741
Phone
+98 81 1827 4192
Fax
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr. Mohammad Haghighi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
65168-4-8741
Phone
+98 81 1827 4192
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)