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The effect of trans cranial direct current stimulation of the brain(tdcs)on ‎cognitive deficit in inpatients with schizophrenia ‎

Protocol summary

Study aim
The effect of trans cranial direct current stimulation of the brain(tdcs)on ‎cognitive deficit in inpatients with schizophrenia ‎
Design
Patients with Schizophrenia admitted to the psychiatric ward of Amir Kabir Hospital in Arak are included in the study. The sample size is 20 people who are Simple randomization with random number to two groups. study is clinical trial and double-blind.
Settings and conduct
Patients with Schizophrenia admitted to the psychiatric ward of Amir Kabir Hospital in Arak are included in the study. The sample size is 20 people who are Simple randomization with random number to two groups. study is clinical trial and double-blind.The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-60 yeaqrs, the presence of criteria for schizophrenia disorder based on DSM IV-TR criteria and clinical interview conducted by the supervisor, no received ECT within one month before entering the study, lack of mental retardation Exclusion criteria: The incidence of side effects that makes the patient unwilling to continue tDCS, need for ECT, epilepsy, dementia, delirium and other cognitive disorders, not pregnancy, lack of medical illness, abuse of substance or alcohol during the last month, except nicotine
Intervention groups
We place 10 patients in the case group and 10 patients in the control group. In the control group, the electrodes are attached but do not stimulate. In the case group, a direct brain electrical stimulation begins with the tDCS device (Medina Medical Manufacturing Company of the United Kingdom). The current is 2 milliAmper for 20 minutes each day for 10 sessions.
Main outcome variables
Working memory, continuous attention, selective attention and executive performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N79
Registration date: 2018-06-02, 1397/03/12
Registration timing: registered_while_recruiting

Last update: 2018-06-02, 1397/03/12
Update count: 0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-20, 1396/03/30
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of trans cranial direct current stimulation of the brain(tdcs)on ‎cognitive deficit in inpatients with schizophrenia ‎
Public title
The effect of trans cranial direct current stimulation of the brain(tdcs)on ‎cognitive deficit in inpatients with schizophrenia ‎
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 yeaqrs The presence of criteria for schizophrenia disorder based on DSM IV-TR criteria and clinical interview conducted by the supervisor no received  ECT within one month before entering the study Lack of mental retardation
Exclusion criteria:
The incidence of side effects that makes the patient unwilling to continue tDCS Need for ECT Epilepsy, dementia, delirium and other cognitive disorders Not pregnancy Lack of medical illness Abuse of substance or alcohol during the last month, except nicotine
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number in division of groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice Chancellor for Research, Payambar Azam Complex, Basij Squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.34

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Working memory
Timepoint
Before starting Tdcs, after 5 sessions and one day after 10 sessions
Method of measurement
Continuous Performance Test

2

Description
continuous attention
Timepoint
Before starting Tdcs, after 5 sessions and one day after 10 sessions
Method of measurement
Continuous Performance Test

3

Description
selective attention
Timepoint
Before starting Tdcs, after 5 sessions and one day after 10 sessions
Method of measurement
Stroop Test

4

Description
executive performance
Timepoint
Before starting Tdcs, after 5 sessions and one day after 10 sessions
Method of measurement
Wechsler Test

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the control group, the electrodes are attached but do not stimulate.
Category
Treatment - Other

2

Description
Intervention group: In the case group, a direct brain electrical stimulation begins with the tDCS device (Medina Medical Manufacturing Company of the United Kingdom). The current is 2 milliAmper for 20 minutes each day for 10 sessions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Anita Alagheman
Street address
Amirkabir hospital, Parastar Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alaghemand@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Arjmandzadegan
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Arjmandzadegan@arakmua.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Ghasemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
ghasemi@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Anita Alaghemand
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Alaghemand@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Maryam Kavei
Position
resident of psychology
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
marmar_kaveh64@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish relevant article in a journal.
When the data will become available and for how long
After publishing the article
To whom data/document is available
researchers who work at university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Anita Alaghemand
What processes are involved for a request to access data/document
They have to send their request to the professor who is the chair of the work and they also must pass administrative process of the university.
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