Determining the rate of reduction of clinical symptoms and improvement of cognitive defects in schizophrenic patients through treatment of stimulation with random noise currents on the prefrontal cortex
Design
The present study is a clinical trial with pre-test, post-test and follow-up. The statistical population of this study is 40 people and they will be randomly assigned to two groups of 20. Random allocation is done by dividing the participants into target groups
Settings and conduct
Location of Beheshti Hospital - non-identical examiner and therapist - pre-test, post-test and one- and two-month follow-up
Participants/Inclusion and exclusion criteria
1- Having the ability of informed consent to participate in research2_Have a minimum age of 18 and a maximum of 65 years 3_have a diagnosis of schizophrenia or schizoaffective disorder4_ The same dose and drug used 5_ Being right-handed 6_ Stabilization in drug treatment for at least 7 weeks before the start and during the research
Intervention groups
The intervention group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 20 minutes.The sham group will also receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 30 seconds.And after the sessions, all the tools will be run again in the post-test, and after two months, the same tools will be run again on the subjects.
The impact of prefrontal tRNS on schizophrenia clinical symptoms and cognitive deficits
Public title
treatment for schizophrenia patients: double-blind randomized controlled trial study
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1- Having the ability of informed consent to participate in research
2_Have a minimum age of 18 and a maximum of 65 years
3_have a diagnosis of schizophrenia or schizoaffective disorder
4_ The same dose and drug used before the start and during the research
5_ Being right-handed
6_ Stabilization in drug treatment for at least 7 weeks
Exclusion criteria:
1_Have a history of suicide and abuse of alcohol and substances other than caffeine and tobacco
2_Have a history of neurological diseases
3_Have a disease related to the scalp
4_Have a history of head trauma
5_ Existence of device or tool in the head
6- Leaving the research after being absent in two consecutive sessions
7- Pregnancy or breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are selected from Convenience judgmental Sampling method ,They will also be randomly assigned to the desired groups. then which subjects are assigned to the two groups of control and experiment by tossing coins.This method is used for two-group clinical trials, according to which one group is called a lion, and the other is called a line, and thus the number of coin samples is tossed
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the clinical evaluator and therapist will be blind to assigning subjects to control and experimental groups. In addition, we use the clinical evaluator separately for baseline assessments and follow-up, and the therapist separately for treatment.Subjects will also be assigned to control groups or blind experiments, so that subjects will not meet outside of the sessions and will visit at times when no other subjects will be present.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
8431575143
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.ZUMS.REC.1400.260
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Negative symptoms:Theoretical definition: It is one of the clinical symptoms in schizophrenia that includes superficial emotion, poor speech, lack of motivation, unhappiness and social transgression.Operational definition: The score that a person gets from the positive and negative symptoms of schizophrenia.Positive symptoms: Theoretical definition includes delusions, delusions, disturbed speech, and disturbed behavior that persist throughout a one-month period.Operational definition: The score that a person gets from the positive and negative symptoms of schizophrenia.
The score that a person gets from the questionnaire for measuring positive and negative symptoms in schizophrenia.
Secondary outcomes
1
Description
Working memory:Theoretical definition: means the ability to store and manipulate information in memory, which is an essential prerequisite for complex cognitive tasks such as learning, reasoning and comprehension.
The score that a person gets from the working memory test in the CANTAB collection.
2
Description
executive function: Theoretical definition: A general structure that encompasses a wide range of cognitive processes and behavioral abilities that include reasoning, problem solving, planning, organizing, working memory, ordering, the ability to pay constant attention, deal with interference, benefit from feedback, and practice. Includes multitasking.
The score that a person gets from the executive function measurement test in the CANTAB collection.
3
Description
Emotion Recognition: A Theoretical DefinitionThe ability to recognize people's emotions through non-verbal expression such as face, voice, or gestures and body movements is a key ability in social interactions and a prerequisite for understanding and predicting and responding appropriately to one's behavior.
The score that a person gets from the emotional recognition test in the CANTAB collection.
4
Description
DepressionTheoretical definition: Depression is a transient or long-term decline in mood. The main characteristic is the feeling of dissatisfaction, which means lack of interest or lack of feeling of pleasure for the activities that the person already enjoys.
The intervention group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 20 minutes.
Category
Treatment - Other
2
Description
The control group will receive random stimulation treatment with a frequency of 100_640 Hz, with an average of 1 mA and a range of 2 mA for 10 sessions of 30 seconds.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Men's emergency department of Shahi
Full name of responsible person
Dear Dr. Ramin Maleki
Street address
Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
+98 21 8670 5504
Email
farahnaz.yosefi76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Parviz Ghezelbash
Street address
Zanjan University of Medical Sciences, Sabouti Blvd., Zanjan Province
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
Dr. Mohsen Dadashi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
+98 21 8670 5504
Email
mohsen.dadashi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Dadashi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
+98 21 8675 6604
Email
mohsen.dadashi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farahnaz Yousefi
Position
Master of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
+98 21 8670 5698
Email
farahnaz.yosefi76@gmail.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 information of individuals except names and confidential information will be published at the end of the research. Publishable information including: treatment changes, results of questionnaires, statistical results of analyzes, dosage and medication used
When the data will become available and for how long
The results of this research will be published three months after the end of the research.
To whom data/document is available
All researchers, researchers, colleagues, and others
Under which criteria data/document could be used
To carry out similar projects and if all the material and intellectual rights of researchers are observed.
From where data/document is obtainable
Contact the following email address to receive the documentation: Farahnaz Yousefi Master of Clinical Psychology farahnaz.yosefi76@gmail.com Address: Department of Clinical Psychology and Psychiatry, Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
What processes are involved for a request to access data/document
The data will be provided to the applicant after receiving the e-mail of the applicant and observing the material and intellectual rights of the researchers.