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Investigation the effect of transcranial direct current stimulation (tDCS) of the brain, as an adjunct to Fluexthine for patient with Obssesive-Compulsive Disorder: A clinical trial

Protocol summary

Summary
The aim of this study is to investigate the effect of transcranial direct current stimulation (tDCS) of the brain, on the symptoms of obsessive-compulsive disorder.In this regard, 60 patients with obsessive-compulsive disorder at psychiatric ward of Arak Amir-Kabir Hospital, will participate. After explaining the study, in case of their consent, demographic information will be received, and those with a score higher than 20 on the Yale-Brown and other criteria for inclusion and exclusion will be enrolled. The subjects will be randomly divided into two intervention and control groups. The anode electrode will be placed in the left dorsolateral cortex (pF3 point; 20/10 EEG), and the cathode electrode will be placed in the lateral side of right contralateral orbit (p8 point; 20/10 EEG). Patients will receive electrical stimulation with 2 mA, for 20 minutes (8 weeks, 3 sessions per week). The results of Yale-Brown Obsessive-Compulsive scale will be recorded before intervention, at 4, 8 and 12 weeks throughout the intervention. In the control group, situation is the same; with the exception that there is no stimulation. All patients are on Fluoxetine 40-80 mg.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030632904N1
Registration date: 2017-07-14, 1396/04/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-14, 1396/04/23
Registrant information
Name
Sadegh Yoosefee
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25332944710
Email address
syoosefee@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of transcranial direct current stimulation (tDCS) of the brain, as an adjunct to Fluexthine for patient with Obssesive-Compulsive Disorder: A clinical trial
Public title
The effect of electrical stimulation of the brain, in patients with obsession disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: The Yale Brown score 20 or more; Age 20 to 60 years; Medication with Fluoxetine; Having at least primary education Exclusion criteria: Lack of cooperation during study despite adequate explanation; Having heart disease; Having neurological disease; Medication except Fluoxetine; Use of benzodiazepines and other antihistamines; ECT in the past two months; Existence of electronic devices and metal in the body; Exacerbation of disease and suicidal thoughts; Pregnancy; Having other psychiatric disorders; Having physical disease; Mental retardation; History of drug and alcohol abuse
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Subjects placed in two groups, using randomized block design.

Secondary Ids

1

Registry name
.
Secondary trial Id
.
Registration date
2017-11-22, 1396/09/01

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences Complex, Basij Square
City
Arak
Postal code
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.ARAKMU.REC.1395.9

Health conditions studied

1

Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-Compulsive Disorder

Primary outcomes

1

Description
Clinical feature of OCD
Timepoint
pre-intervention, at 4, 8 and 12 weeks throughout the intervention
Method of measurement
Yale-Brown Obsessive Compulsive Scale (YBOCS)

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group: Patients will attach through electrodes to the tDCS device, with 2 mA, for 20 minutes (8 weeks, 3 sessions per week); but stimulation will not be applied.
Category
Treatment - Devices

2

Description
Intervention Group: Transcranial direct electrical stimulation of the brain with 2 mA, for 20 minutes (8 weeks, 3 sessions per week) using tDCS device
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amir-Kabir Hospital, psychiatric ward
Full name of responsible person
Dr Bahman Salehi
Street address
Amir-Kabir Hospital, Parastar Square
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chanceller for research, Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafei
Street address
Vice chanceller for research, Arak University of Medical Sciences Complex, Basij Square
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller for research, Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Victoria Safari
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
Psychiatry Department, Amir-Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
+98 86 3313 2510
Email
ms.prn74@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Bahman Salehi
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatry Department, Amir-Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
+98 33132510
Email
basalehi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Sadegh Yoosefee
Position
Ph.D. In Neurosience
Other areas of specialty/work
Street address
Neurology Department, Shahid Beheshti Hospital, Shahid Beheshti Boulevard
City
Qom
Postal code
Phone
Fax
Email
syoosefee@muq.ac.ir; yoosefee@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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