Protocol summary

Study aim
1) Determination of working memory`s function of schizophrenic patients with recent onset 2) Determination of working memory`s function of schizophrenic patients after tDCS and Sham treatments 3) Comparison of changes in working memory`s function of schizophrenic patients after sham and tDCS treatments
Design
Double-blind randomized clinical trial with control group, with one intervention in each group, for 40 patients, with a two-week intervention and follow-up for one week
Settings and conduct
In this trial, 40 patients with schizophrenia will be randomly assigned to two groups of intervention and control group. Simple randomization will be performed by Randlist. Both patients and evaluaters will be blinded. Patients will receive the assigned intervention, 2 sessions per week, for two weeks, at the morning. Working memory task will be used prior and after each session of tDCS and control, and also one week after the end of study. At the end of each session patients will score fatigue with visual analogue scale (VAS). Differences between measurements as well as between groups will be analyzed with repeated measures ANOVA and if a significant difference is available the timing will be defined
Participants/Inclusion and exclusion criteria
inclusion criteria: 1. diagnosis of schizophrenia based on semi structured standard interview 2.onset<2 years 3.drug naive or receiving an stable dose on antipsychotic 5.no medication affecting central nervous system exclusion criteria: 1.History of/present epilepsy 2.malfunctions of blood circulation 3.metabolic disorders 4. hormonal disorders 6.established cognitive disorders 7.untreated poor vision 8.handicapped hands 9.intellectual disability (IQ<75)
Intervention groups
An intervention was conducted on 40 schizophrenic patients admitted to university clinics or with schizophrenia diagnosed at Razi Hospital. These patients will be randomly divided into intervention and control groups.
Main outcome variables
Working memory

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160528028118N2
Registration date: 2018-03-17, 1396/12/26
Registration timing: registered_while_recruiting

Last update: 2018-03-17, 1396/12/26
Update count: 0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Sara Farhang
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 984133803353
Email address
farhangs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for psychiatry and behavioral sciences, Tabriz University of Medical Sciences
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of brain stimulation therapy by tDCS on the working memory of patients with schizophrenia with a recent onset
Public title
The effect of tDCS brain stimulation on memory improvement in schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. diagnosis of schizophrenia based on semi structured standard interview 2.onset<2 years 3.age>18 years old 4.drug naive or receiving an stable dose on antipsychotic 5.no medication affecting central nervous system
Exclusion criteria:
1.History of/present epilepsy 2.malfunctions of blood circulation 3.metabolic disorders 4. hormonal disorders 5.established cognitive disorders 6.untreated poor vision 7.handicapped hands 8.intellectual disability (IQ<75)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, with "individuals" as units of randomization, by a randomized list generated by Randlist software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and research team of Outcome are unaware of the allocation of study groups.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of tabriz university of medical science
Street address
Tabriz, Gulgasht street, tabriz university of medical science, The central building no.2, third floor
City
tabriz
Province
East Azarbaijan
Postal code
51999
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1142

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 intervention, during sessions of intervention, after intervention, onemonth after intervention
Method of measurement
Working memroy task

Secondary outcomes

1

Description
fatigue
Timepoint
after each session of intervention
Method of measurement
visual analouge scale

Intervention groups

1

Description
Transcranial direct current stimulation, two session per week
Category
Treatment - Devices

2

Description
Control group: Sham Transcranial direct current device with no stimulation, two session per week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Sara Farhang
Street address
Razib hospital, Ael-Goli Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51999
Phone
+98 41 3380 3353
Email
farhangs@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Fakhari
Street address
Razib Hospital, Ael-Goli Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51999
Phone
+98 41 3380 3353
Email
farkharia@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Habibeh Barzegar
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Razib Hospital, Ael-Goli Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51999
Phone
+98 41 3380 3353
Fax
Email
barzegar.9005@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sara Farhang
Position
Psychiatrist/ assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razib Hospital, Ael-Goli Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51999
Phone
+98 41 3380 3353
Fax
Email
FARHANGS@TBZMED.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behnaz Hosseintoraby
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Razib Hospital, Ael-Goli Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51999
Phone
+98 9841333803353
Email
beh.hoseini@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
all of anonymous data could be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
researchers
Under which criteria data/document could be used
formal request from the supporting organization
From where data/document is obtainable
research center for psychiatry and behavioral sciences
What processes are involved for a request to access data/document
submitting the request and reason as a proposal
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