This study is a randomized single blind Sham control study for evaluation of 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 25 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 resting motor threshold (RMT) for a total of 12.5 minutes of stimulation. Then following this, HFR stimulation will be applied at the same parameters. Therefore a total of 25 minutes of stimulation will be delivered.Two groups will be compared regarding cognition improvement using PASSAT, Digit Symbol and Digit Span measures,in 1st,last and two weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110419808N1
Registration date:2014-11-28, 1393/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Mehran Shaygan Fard
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0160
Email address
m.shaygan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Cognitive Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients of Refractory Obsessive Compulsive Disorder
Public title
Study of Effects of Repetitive Transcranial Magnetic Stimulation on cognition of Refractory Obsessive Compulsive Disorder Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: have a DSM-IV-TR diagnosis of OCD; ages between 18 and 65 years old; 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; score of greater than or equal to 17 on the Y-BOCS. Exclusion Criteria: a history of DSM-IV-TR substance dependence in the last 6 months or DSM-IV-TR substance abuse in the last month; a concomitant major unstable medical or neurologic illness or have had a history of seizures; acutely suicidal; being pregnant; metal implants; if they are currently (or in the last 4 weeks) taking more than lorazepam 2 mg daily (or equivalent), monoamine oxidase inhibitors, and/or bupropion (due to its associated increased risk for seizures); Education lower than 2nd class of guidance school
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:
10
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, Hamedan
City
Hamedan
Postal code
Approval date
2014-10-06, 1393/07/14
Ethics committee reference number
16/35/9/3462/پ
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
Rate of cognition in refractory OCD
Timepoint
after 10th, 20th sessions of rTMS or sham
Method of measurement
PASSAT, Digit symbol, Digit Span
Secondary outcomes
empty
Intervention groups
1
Description
Intervention (refractory transcranial magnetic stimulation (rTMS)): 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 resting motor threshold (RMT) for a total of 25 minutes of stimulation; Then following this, high frequency right (HFR) stimulation will be applied at the same parameters. Therefore a total of 50 minutes of stimulation will be delivered.
Category
Treatment - Devices
2
Description
Control (Sham condition): 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 total of 50 minutes, but with the coil angled 45-90 degrees away from the skull in a single-wing tilt position. This method produces sound and somatic sensation (e.g., contraction of scalp muscles) like those with active stimulation but with minimal direct brain effects. Participants will remain blind to the treatment condition.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Dr Mehran Shayganfard
Street address
Mirzade eshghi st
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Dr. Mohamad Ahmadpanah
Street address
Farshchian Hospital, Mirzade eshghi st
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Dr Mehran Shaygan Fard
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzade eshghi st
City
Hamedan
Postal code
Phone
+98 81 3827 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
Associate Professor
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzade Eshghi st
City
Hamedan
Postal code
Phone
+98 81 3827 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 Science
Full name of responsible person
Dr Mehran Shaygan Fard
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamedan
Postal code
Phone
+98 81 3827 4192
Fax
Email
mshayganfard@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)