Efficacy of of transcranial direct stimulation in schizophrenia patients with dominant negative symptoms
Design
A clinical trial with real and sham stimulation groups, with parallel, double blind and randomized groups.
Sample size was estimated using G power software with an effect size of 0.61 and alpha of 0.05 and 40 individuals. This number of samples is consistent with what has been stated in the research literature.
A sample of 40 schizophrenic patients with predominant negative symptoms was randomly assigned to the 20 binary blocks of AB by the supervisor in two groups of 20 randomly assigned to the Web.
Settings and conduct
The study will be conducted at Zanjan University of Medical Sciences. Also In this study, participants and data analyzer will not be aware of the randomization process.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Ages 18 to 65 years
People with DSM5 who have been diagnosed with schizophrenia and have predominantly negative symptoms.
3. Patients undergoing constant antipsychotic regimen for at least 4 weeks.
Exclusion criteria:
1. Dependence on materials
2. Concurrent psychiatric disorder (including suicidal individuals)
3. Neurological diseases such as seizures, strokes, or cerebrovascular diseases
4. Physical illness such as malignancy, heart attack infection
5. Pregnancy
6. The existence of metal implants in the body
7. Skin disease involving scalp
Intervention groups
The first group received real tDCS intervention, the second group received placebo tDCS intervention.
Main outcome variables
Negative symptoms, positive symptoms, and degree of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200203046366N1
Registration date:2020-10-29, 1399/08/08
Registration timing:retrospective
Last update:2020-10-29, 1399/08/08
Update count:0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
parya jalili khiavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4002
Email address
dr.parya.jalili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
2019-06-21, 1398/03/31
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-11-21, 1398/08/30
Scientific title
Determination of therapeutic effect of tDCS in schizophrenic patients with predominant negative symptoms
Public title
Efficacy of transcranial direct current stimulation(tDCS) on schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People diagnosed with schizophrenia on thebasis of DSM5
Patients receiving fixed antipsychotic treatment regimen for at least 4 weeks
Exclusion criteria:
1-substance dependency
comorbid psychiatric disorder(including suicidal individuals)
neurologic diseases such as epilepcy,CVA or cerebral vessels disease
physical disease such as malignancy,infections and heart failure, pragnancy, the existence of a metal implant in the body and skin disease involving scalp
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization, individual, layered, statistical software.
A sample of 40 schizophrenic patients with dominant negative symptoms by random sampling available on the web at https://www.sealedenvelope.com,The number of 20 binary blocks AB is assigned by the supervisor in two groups of 20.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know in which intervention group AB (real and sham intervention) are. 2- Data analysis is performed by the data analyzer. As they are not aware of the nature of the groups AB. All data will be encrypted.
Placebo
Used
Assignment
Parallel
Other design features
This clinical trial consists of two groups: real and sham intervention, double blind and randomized.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Square, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.ZUMS.REC.1398.102
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20-F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
Description
Positive and negative symptoms of schizophrenia
Timepoint
Pre-test, Post-test and follow up (one month after post-test)
Method of measurement
Positive and Negative Syndrome Scale
2
Description
Negative Symptoms
Timepoint
Pre-test, Post-test and follow up (one month after post-test)
Method of measurement
Scale for the Assessment of Negative Symptoms
3
Description
Depression
Timepoint
Pre-test, Post-test and follow up (one month after post-test)
Method of measurement
Calgary Depression Scale for Schizophrenia
Secondary outcomes
empty
Intervention groups
1
Description
Actual excitation of 2 mA for 20 minutes and placement of the cathode electrode in the left DLPFC and anode in the patient's right Orbito Frontal. The intervention consists of 15 sessions per day.
Category
Rehabilitation
2
Description
Intervention group: The 2 mA stimulation is stopped after 60 seconds of the cathode electrode in the left DLPFC and the anode in the patient's right Orbito Frontal, the intervention consisting of 15 treatment sessions per day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Medical Center
Full name of responsible person
Priya Jalili Khiyavi
Street address
Ark Gate - Dr. Beheshti Hospital
City
zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Fax
+98 24 3377 0757
Email
dr.parya.jalili@gmail.com
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=29
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shogli
Street address
Azadi Square, Zanjan University of Medical Sciences
City
zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 3342 0204
Fax
+98 24 3342 0678
Email
amayeshzone6@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=29
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Parya Jalili Khiavi
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ark Gate, Dr. Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Fax
+98 24 3354 2403
Email
dr.parya.jalili@gmail.com
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=29
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parya Jalili Khiavi
Position
Resident of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ark Gate, Dr. Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Fax
+98 24 3354 2403
Email
dr.parya.jalili@gmail.com
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=29
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parya Jalili Khiavi
Position
Resident of psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ark Gate, Dr. Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Fax
+98 24 3354 2403
Email
dr.parya.jalili@gmail.com
Web page address
http://zums.ac.ir/
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
Not applicable
Title and more details about the data/document
All of information related to main outcome will be published.
When the data will become available and for how long
Start the access period from 2020
To whom data/document is available
Researchers and clinicians working in academic and scientific institutions
Under which criteria data/document could be used
Access to documents is possible to inform other researchers and clinicians. Access to documents is possible to work with the researcher.