The Effect of transcranial Direct Current Stimulation on the Reduction of Negative Symptoms in Schizophrenic Patients
Design
This clinical trial has a community-based control group with parallel groups. This is a randomized, double-blind, phase 2-3 study with 32 patients. Randomization will be done using random numbers created by the computer. The patient and the outcome assessor are not aware of the type of intervention.
Settings and conduct
Qualified patients will be randomly divided into two intervention tDCS and control tDCS groups. Accidental randomization will be performed based on blocking. This clinical trial has a community-based, action-oriented control group with parallel and double-blind groups. The patient and the evaluator do not know the type of intervention, the type of block, and the sample size in each block. this study will done in Golestan hospital, Ahvaz
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of DSM-5 schizophrenia, no liver disease, no history of treatment with direct transcranial electrical during the last six months, duration of illness should be more than one year and age over 18 years.
ٍExclusion criteria: Patient with depression; bipolar disorder; epilepsy and Parkinson's; pregnant or breastfeeding woman and drug abuse in recent months
Intervention groups
Qualified patients based on criteria will be randomly divided into two groups of tDCS and fictitious tDCS.
Intervention group: The true tDCS group will receive 2 sessions of the right anode and left cathode. The intervention will do randomly for 20 minutes and 2 mA on the lateral posterior frontal area. Control group: the right anode and left cathode will place on the forehead but the machine will not turn on.
Main outcome variables
Negative sign of Schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100520003979N10
Registration date:2021-08-02, 1400/05/11
Registration timing:prospective
Last update:2021-08-02, 1400/05/11
Update count:0
Registration date
2021-08-02, 1400/05/11
Registrant information
Name
Forugh Riahi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
riahi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of transcranial Direct Current Stimulation on the Reduction of Negative Symptoms in Schizophrenic Patients
Public title
The Effect of transcranial Direct Current Stimulation on Schizophrenic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on DSM-5
No liver disease
No history of treatment with direct transcranial electrical during the last six months
The duration of the disease is more than one year
Age over 18 years old
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The double-blind side includes the patient and the person who is responsible for assessing the outcome. The patient knows that he has participated in a study but does not know what treatment is receiving. The assessor does not know which patient was involved in the intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-02-02, 1399/11/14
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.149
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Negative signs of Schizophrenia
Timepoint
At the start of treatment, weeks 2, 4
Method of measurement
Overal scale score PANS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The true tDCS group will receive 2 sessions of the right anode and left cathode stimulation sessions by an experienced technician with no knowledge of the subject and an interventional therapist. The intervention will do randomly for 20 minutes and 2 mA on the lateral posterior frontal area
Category
Treatment - Other
2
Description
Control group: the right anode and left cathode will place on the forehead by an experienced technician with no knowledge of the subject but the machine will not turn on.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Seyyed Mohmmad Hasani
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
kalame_saeed@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz Junishapur University of Medical Sciences,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
m.ahmadimoghadam@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Forough Riahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Riahi13@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Forough Riahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Riahi13@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyyed Mohammad hasani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
kalame_saeed@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available