The pupose of This study is investigate and achive the best treament protocol for reducing symptoms of OCD.The Target population is 18 to 40 years with OCD Symptoms, referring to the Brain & Cognition Clinic.By the psychiatrist,YBOCS Test scores were higher than 16,They will be selected according to entry and exit criteria and will be divided into 4 groups.symptoms were measured before, after and one month after treatment.
Design
Forty subjects will participate in this double blind randomized clinical study.Three intervention and a sham group will participate.sham controlled clinical trial with a parallel group design and followed for one Month.Finally the data will be analyzed by SPSS software.
Settings and conduct
This survey is a semi-experiment study with Random selection in control and experimental groups, with pretest and post test and follow up.statistical society of this survey is 18 to 45 years old patients suffering from compulsive obsessive disorder going to brain and cognition clinic. sampling methods are 40 persons who were diagnozed to suffer from obssessive disorder after clinical interview by psychiatrist based on DSM5 diagnosis criterion chach 16 or higher grade in(Y-BOCS) Questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis by a psychiatrist based on DSM5; Score 16 from Yale BrownTest; No Neurological problems.
Exclusion criteria: mental retardation; Addiction to drugs and alcohol; psychotic disorders; epilepsy and seizure; pregnancy; patient dissatisfaction.
Intervention groups
30 patients will be placed in 3 groups for 5 days (twice a day) at 2 mA with the anode over the right Occipital and the cathode over the orbital frontal cortex and the complementary motor cortex and the left Occipital area.10 people in the control group who will be sham stimulated.
Main outcome variables
Severity of obsessive-compulsive symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180624040217N1
Registration date:2018-08-01, 1397/05/10
Registration timing:registered_while_recruiting
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
sara Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3441 8143
Email address
sarahakbari64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic efficacy of different suggested trans cranial direct current stimulation protocols in obsessive compulsive disorder
Public title
Find the best brain electrical stimulation protocol for obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obsessive-Compulsive Disorder diagnosis based on DSM-5
Age range 18 to 45
No neurologic deficits.
No dependence on drugs and alcohol
Test score of 16 and higher than the YBOCS
Exclusion criteria:
Pregnancy and lactation
Low IQ
The presence of metal or implant in the head
Patient dissatisfaction or withdrawal
Epilepsy and seizure
Psychotic disorders
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research,Participating groups and patients, Evaluator,And who analyzes the data that is out of the team, and the caregivers in the research will be blind.They will be randomly assigned to the test and control groups.Those controls depending on the group that participated in it, and Beside them, they will receive the sham stimulant protocol.Exactly the same operation without electrical stimulation on sham intervention group will be implemented.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Karaj Branch
Street address
Islamic Azad University of Kararaj , Moujzen Blvd, Rajai Shahr, Karaj Town
City
Karaj
Province
Alborz
Postal code
3148635731
Approval date
2017-11-23, 1396/09/02
Ethics committee reference number
IR.IAU.K.R.E.C.RC
Health conditions studied
1
Description of health condition studied
OCD
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive Compulsive Symptoms
Timepoint
Before the intervention after the last intervention
Method of measurement
(YBOCS) Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 patients were treated for 5 consecutive days, 30 minutes twice daily, Anode applied on the right Occipital and cathode in the Orbitofrontal cortex area at 2 mA.
Category
Treatment - Devices
2
Description
Intervention group: 10 patients were treated for 5 consecutive days, 30 minutes twice daily,Anode applied on the right Occipital and cathode over the Pre-SMA cortex area at 2 mA.
Category
Treatment - Devices
3
Description
Intervention group: 10 patients were treated for 5 consecutive days, 30 minutes twice daily,Anode applied over the right Occipital and cathode over the left Occipital area at 2 mA.
Category
Treatment - Devices
4
Description
Control group: 10 patients for 5 consecutive days, 30 minutes twice a day over the Occipital Will be test Symbolically and without brain stimulation.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain & Cognition Clinic
Full name of responsible person
Peyman Hasaini Abharian
Street address
No 33,East Zartosht Street,Tehran Province,Tehran
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8609 3160
Fax
+98 21 8880 2063
Email
info@bacogc.com
Web page address
http://bacogc.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Peyman Hasni Abarian
Street address
No 33, East Zartosht Ave, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8880 2063
Fax
+98 21 8890 0526
Email
info@bacogc.com
Web page address
http://www.bcclinic.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sponsor for the study
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
Islamic Azad University
Full name of responsible person
Sara Akbari
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
karaj University; Mouzen Blvd; Rajai Shahr; Karaj Town
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3441 8143
Fax
+98 26 3441 8156
Email
info@kiau.ac.ir
Web page address
http://www.kiau.ac.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Peyman Hasani Abhariyan
Position
M.D.Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No 33,East Zartosht Street,Valiasr Blve,Tehran
City
Tehran
Province
Tehran
Postal code
3148635731
Phone
+98 21 8880 2063
Fax
+98 21 8890 0526
Email
info@kiau.ac.ir
Web page address
http://www.bacogc.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Akbari
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
karaj University; Mouzen Blvd; Rajai Shahr; Karaj Town
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3441 8143
Fax
+98 26 3441 8156
Email
info@kiau.ac.ir
Web page address
http://www.kiau.ac.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
No - There is not 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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available