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Protocol summary
Cross-Over clinical trial with repeated measures and one-way blind with control group.23 subjects. The order of presenting the sessions to each subject is random and by lot.
In this study, three situations are considered and repeated measures analysis of variance is used.23 subjects. The order of presenting the sessions to each subject is random and by lot.
Cross-Over clinical trial withIn this study, three situations are considered and repeated measures and one-way blind with control group.23analysis of variance is used.23 subjects. The order of presenting the sessions to each subject is random and by lot.
کارآزمایی بالینی متقاطع با اندازه گیری مکرر و به صورت یک سو کور و با گروه کنترل. 23 آزمودنی.ترتیب ارائه جلسات به هر آزمودنی تصادفی و به صورت قرعه کشی می باشد.
در این مطالعه سه موقعیت در نظر گرفته شده است و از تحلیل واریانس با اندازه گیری مکرر استفاده شده است. 23 آزمودنی.ترتیب ارائه جلسات به هر آزمودنی تصادفی و به صورت قرعه کشی می باشد.
کارآزمایی بالینی متقاطعدر این مطالعه سه موقعیت در نظر گرفته شده است و از تحلیل واریانس با اندازه گیری مکرر و به صورت یک سو کور و با گروه کنترلاستفاده شده است. 23 آزمودنی.ترتیب ارائه جلسات به هر آزمودنی تصادفی و به صورت قرعه کشی می باشد.
General information
Parallel
Crossover
paralcross
No
Yes
1
empty
3
3
No
Yes
1
empty
3
3
empty
An error occurred in the design section of the study.In total, there are 23 subjects who are tested in three stages. Each subject acts as its control group.
Corrected in the study groups (Cross over).
Also in the abstract, the design was modified.
An error occurred in the design section of the study.In total, there are 23 subjects who are tested in three stages. Each subject acts as its control group. Corrected in the study groups (Cross over). Also in the abstract, the design was modified.
empty
در قسمت طراحی مطالعه خطا اتفاق افتاده.
به طور کلی 23 آزمودنی وجود دارد که در سه مرحله از آن ها آزمون گرفته می شود. هر آزمودنی هم به عنوان گروه کنترل خود عمل می کنه.
در قسمت گروه های مورد مطالعه (متقاطع) تصحیح شد.
همچنین در قسمت چکیده، طراحی اصلاح شد.
در قسمت طراحی مطالعه خطا اتفاق افتاده. به طور کلی 23 آزمودنی وجود دارد که در سه مرحله از آن ها آزمون گرفته می شود. هر آزمودنی هم به عنوان گروه کنترل خود عمل می کنه. در قسمت گروه های مورد مطالعه (متقاطع) تصحیح شد. همچنین در قسمت چکیده، طراحی اصلاح شد.
empty
Each participant receives intervention in three different situations. Positions include: 1) Anodal Dlpfc (F3)/ Cathodal Vmpfc (Fp2). 2) Anodal Vmpfc (Fp2)/ Cathodal Dlpfc (F3). 3) Sham
Each participant receives intervention in three different situations. Positions include: 1) Anodal Dlpfc (F3)/ Cathodal Vmpfc (Fp2). 2) Anodal Vmpfc (Fp2)/ Cathodal Dlpfc (F3). 3) Sham
empty
هر یک از شرکت کنندگان در سه موقعیت متفاوت مداخله دریافت می کنند. موقعیت ها عبارتند از: 1) تحریک آنودال در قشر پیش پیشانی خلفی - جانبی چپ (F3) و تحریک کاتودال در قشر شکمی - میانی راست (Fp2). 2) تحریک آنودال در قشر شکمی - میانی راست (Fp2) و تحریک کاتودال در قشر پیش پیشانی خلفی - جانبی چپ (F3). 3) تحریک ساختگی
هر یک از شرکت کنندگان در سه موقعیت متفاوت مداخله دریافت می کنند. موقعیت ها عبارتند از: 1) تحریک آنودال در قشر پیش پیشانی خلفی - جانبی چپ (F3) و تحریک کاتودال در قشر شکمی - میانی راست (Fp2). 2) تحریک آنودال در قشر شکمی - میانی راست (Fp2) و تحریک کاتودال در قشر پیش پیشانی خلفی - جانبی چپ (F3). 3) تحریک ساختگی
empty
Each participant receives intervention in three different situations. Positions include: 1) Anodal Dlpfc (F3)/ Cathodal Vmpfc (Fp2). 2) Anodal Vmpfc (Fp2)/ Cathodal Dlpfc (F3). 3) Sham
Each participant receives intervention in three different situations. Positions include: 1) Anodal Dlpfc (F3)/ Cathodal Vmpfc (Fp2). 2) Anodal Vmpfc (Fp2)/ Cathodal Dlpfc (F3). 3) Sham
empty
هر یک از شرکت کنندگان در سه موقعیت متفاوت مداخله دریافت می کنند. موقعیت ها عبارتند از: 1) تحریک آنودال در قشر پیش پیشانی خلفی - جانبی چپ (F3) و تحریک کاتودال در قشر شکمی - میانی راست (Fp2). 2) تحریک آنودال در قشر شکمی - میانی راست (Fp2) و تحریک کاتودال در قشر پیش پیشانی خلفی - جانبی چپ (F3). 3) تحریک ساختگی
هر یک از شرکت کنندگان در سه موقعیت متفاوت مداخله دریافت می کنند. موقعیت ها عبارتند از: 1) تحریک آنودال در قشر پیش پیشانی خلفی - جانبی چپ (F3) و تحریک کاتودال در قشر شکمی - میانی راست (Fp2). 2) تحریک آنودال در قشر شکمی - میانی راست (Fp2) و تحریک کاتودال در قشر پیش پیشانی خلفی - جانبی چپ (F3). 3) تحریک ساختگی
Intervention groups
#1
Intervention group: Left anode/Right cathode intervention; In this intervention, the positive electrode (anode) is placed on the dorsolateral prefrontal cortex (DLPFC) , which leads to increased neuronal activity, and the negative electrode (cathode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Intervention group: Left anode/Right cathode intervention; In this intervention, the positive electrode (anode) is placed on the left dorsolateral prefrontal cortex (DLPFC) , which leads to increased neuronal activity, and the negative electrode (cathode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Intervention group: Left anode/Right cathode intervention; In this intervention, the positive electrode (anode) is placed on the left dorsolateral prefrontal cortex (DLPFC) , which leads to increased neuronal activity, and the negative electrode (cathode) is placed on the right ventromedial prefrontal cortex (vmPFC)
#2
Intervention group: Left cathode/Right anode intervention; In this intervention, the negative electrode (cathode) is placed on the dorsolateral prefrontal cortex (DLPFC) , which leads to a decrease in neuronal activity in this area, and the positive electrode (anode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Intervention group: Left cathode/Right anode intervention; In this intervention, the negative electrode (cathode) is placed on the left dorsolateral prefrontal cortex (DLPFC) , which leads to a decrease in neuronal activity in this area, and the positive electrode (anode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Intervention group: Left cathode/Right anode intervention; In this intervention, the negative electrode (cathode) is placed on the left dorsolateral prefrontal cortex (DLPFC) , which leads to a decrease in neuronal activity in this area, and the positive electrode (anode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Recruitment centers
#1
Name of recruitment center - English: درمانگاه دانشکده علوم رفتاری و سلامت روان
Name of recruitment center - Persian: Clinic of the Faculty of Behavioral Sciences and Mental Health
Full name of responsible person - English: مریم مجیدی نژاد
Full name of responsible person - Persian: Maryam Majidinezhad
Street address - English: ستارخان، خیابان نیایش، خیابان شهیدمنصوری
Street address - Persian: Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City - English: تهران
City - Persian: Tehran
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613111
Phone: +98 21 6655 1655
Fax:
Email: maryam.majidinezhad001@gmail.com
Web page address:
Name of recruitment center - English: Clinic of the Faculty of Behavioral Sciences and Mental Health
Name of recruitment center - Persian: درمانگاه دانشکده علوم رفتاری و سلامت روان
Full name of responsible person - English: Maryam Majidinezhad
Full name of responsible person - Persian: مریم مجیدی نژاد
Street address - English: Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
Street address - Persian: ستارخان، خیابان نیایش، خیابان شهیدمنصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613111
Phone: +98 21 6655 1655
Fax:
Email: maryam.majidinezhad001@gmail.com
Web page address:
Name of recruitment center - English: درمانگاه دانشکده علوم رفتاری و سلامت روان Name of recruitment center - Persian: Clinic of the Faculty of Behavioral Sciences and Mental Health Name of recruitment center - Persian: درمانگاه دانشکده علوم رفتاری و سلامت روان Full name of responsible person - English: مریم مجیدی نژادMaryam Majidinezhad Full name of responsible person - Persian: Maryam Majidinezhadمریم مجیدی نژاد Street address - English: ستارخان، خیابان نیایش، خیابان شهیدمنصوری Street address - Persian: Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran Street address - Persian: ستارخان، خیابان نیایش، خیابان شهیدمنصوری City - English: تهرانTehran City - Persian: Tehranتهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613111 Phone: +98 21 6655 1655 Fax: Email: maryam.majidinezhad001@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دانشگاه علوم پزشکی ایران، دانشگاه علوم پزشکی ایران
Full name of responsible person - Persian: Iran University of Medical Sciences, Iran University of Medical Sciences
Street address - English: Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: adminsite@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reza Arezoomandan
Full name of responsible person - Persian: رضا آرزومندان
Street address - English: Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 86701
Fax:
Email: adminsite@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دانشگاه علوم پزشکی ایران، دانشگاه علوم پزشکی ایرانReza Arezoomandan Full name of responsible person - Persian: Iran University of Medical Sciences, Iran University of Medical Sciencesرضا آرزومندان Street address - English: Iran University of Medical Sciences, Hemmat Highway next to Milad Tower, Tehran Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵1449614535 Phone: +98 21 86701 Fax: Email: adminsite@iums.ac.ir Web page address:
Protocol summary
Study aim
The effect of Transcranial direct current stimulation (tDCS) in the dorsolateral prefrontal cortex and ventromedial prefrontal cortex on emotional bias, reduction of mind wandering and improvement of affect in patients with major depressive disorder
Design
In this study, three situations are considered and repeated measures analysis of variance is used.23 subjects. The order of presenting the sessions to each subject is random and by lot.
Settings and conduct
each subject was intervened in three sessions with an interval of 72 hours. After receiving the consent letter and explaining the steps of the test, electrodes were placed on their head. After 5 minutes from the time of stimulation, the response to the computer tests began. In order to control the effect of learning the tests and to create a controlled experimental method, the order of individuals in each of the stages stimulation was done randomly. The electric current was1/5m.A for 20 min. The study site was the clinic of the School of Behavioral Sciences and Mental Health
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of MDD, Being right-handed, 20 to 40 years
Exclusion criteria: any serious medical conditions, History of seizures, Existence of intracranial implants, Pregnancy, Acute vision problems
Intervention groups
1.the anode is placed on the left DLPFC , which leads to increased neuronal activity in this region, and the cathode is placed on the right vmPFC.
2. the cathode is placed on the DLPFC, which leads to a decrease in neuronal activity in this region, and the anode is placed on the right vmPFC.
3.electrodes are placed on the subject's head for 15 minutes like a real stimulus, but no electric current enters the subject except for the first and the last 30 seconds of the session. This session is considered as control.
Main outcome variables
emotional bias, mind wandering, affect
General information
Reason for update
An error occurred in the design section of the study.In total, there are 23 subjects who are tested in three stages. Each subject acts as its control group.
Corrected in the study groups (Cross over).
Also in the abstract, the design was modified.
Acronym
IRCT registration information
IRCT registration number:IRCT20211207053315N1
Registration date:2021-12-29, 1400/10/08
Registration timing:retrospective
Last update:2022-01-29, 1400/11/09
Update count:2
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Maryam Majidinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3296
Email address
maryam.majidinezhad001@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
2021-05-02, 1400/02/12
Actual recruitment end date
2021-09-05, 1400/06/14
Trial completion date
2021-09-05, 1400/06/14
Scientific title
The role of transcranial direct current stimulation on emotional bias, reduction of mind-wandering and affect for patients with depression disorder
Public title
The role of transcranial direct current stimulation on emotional bias, reduction of mind-wandering and affect for patients with depression disorder
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
psychiatric diagnosis of depressive disorder
Age range 20-40 years
Being right-handed
Exclusion criteria:
any serious medical conditions such as a history of trauma or head surgery
History of seizures
Existence of intracranial implants
Pregnancy
acute vision problems
Age
From 20 years old to 40 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
3
Each participant receives intervention in three different situations. Positions include: 1) Anodal Dlpfc (F3)/ Cathodal Vmpfc (Fp2). 2) Anodal Vmpfc (Fp2)/ Cathodal Dlpfc (F3). 3) Sham
Actual sample size reached:
23
More than 1 sample in each individual
Actual sample size in each individual:
3
Each participant receives intervention in three different situations. Positions include: 1) Anodal Dlpfc (F3)/ Cathodal Vmpfc (Fp2). 2) Anodal Vmpfc (Fp2)/ Cathodal Dlpfc (F3). 3) Sham
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were unaware of the type of stimulus they received. The order of placement of individuals in each stage of the research was done randomly using a lottery.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.IUMS.REC.1399.1431
Health conditions studied
1
Description of health condition studied
Major depression disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
emotional bias
Timepoint
Simultaneously with the intervention
Method of measurement
the score that the subject has tested in the computer test of emotional faces (Dot-probe)
2
Description
Mind wandering
Timepoint
Simultaneously with the intervention
Method of measurement
the score that the subject has tested in the computer test of SART
3
Description
affect
Timepoint
Before and after each stimulation session
Method of measurement
the score that the subject achieves on the PANAS positive and negative emotion scale.
Secondary outcomes
1
Description
Side effects of tDCS: Headache, dizziness, burning, itching
Timepoint
Immediately after the actual stimulation and sham condition
Method of measurement
TDCS Side Effects Questionnaire
Intervention groups
1
Description
Intervention group: Left anode/Right cathode intervention; In this intervention, the positive electrode (anode) is placed on the left dorsolateral prefrontal cortex (DLPFC) , which leads to increased neuronal activity, and the negative electrode (cathode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Category
Diagnosis
2
Description
Intervention group: Left cathode/Right anode intervention; In this intervention, the negative electrode (cathode) is placed on the left dorsolateral prefrontal cortex (DLPFC) , which leads to a decrease in neuronal activity in this area, and the positive electrode (anode) is placed on the right ventromedial prefrontal cortex (vmPFC)
Category
Diagnosis
3
Description
Intervention group: Sham intervention; In this intervention, the anode and cathode electrodes are placed on the subject's head for 15 minutes like a real stimulus, but no electric current enters the subject except for the first 30 seconds of the beginning and the end of the session. This session is considered as control
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of the Faculty of Behavioral Sciences and Mental Health