Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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emotional bias, mind wandering, affect
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211207053315N1
Registration date:
2021-12-29, 1400/10/08
Registration timing:
retrospective
Last update:
2022-03-03, 1400/12/12
Update count:
2
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Registration date
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2021-12-29, 1400/10/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-09, 1400/01/20
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Expected recruitment end date
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2021-08-06, 1400/05/15
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Actual recruitment start date
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2021-05-02, 1400/02/12
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Actual recruitment end date
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2021-09-05, 1400/06/14
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Trial completion date
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2021-09-05, 1400/06/14
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Scientific title
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The role of transcranial direct current stimulation on emotional bias, mind-wandering and affect for patients with depression disorder
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Public title
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The role of transcranial direct current stimulation on emotional bias, mind-wandering and affect for patients with depression disorder
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Purpose
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Other
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 40 years old
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Gender
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Both
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Phase
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0
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Groups that have been masked
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Sample size
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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
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-16, 1399/12/26
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Ethics committee reference number
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IR.IUMS.REC.1399.1431
Health conditions studied
1
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Description of health condition studied
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Major depression disorder
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ICD-10 code
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F32
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ICD-10 code description
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Major depressive disorder, single episode
Primary outcomes
1
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Description
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emotional bias
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Timepoint
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Simultaneously with the intervention
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Method of measurement
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the score that the subject has tested in the computer test of emotional faces (Dot-probe)
2
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Description
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Mind wandering
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Timepoint
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Simultaneously with the intervention
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Method of measurement
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the score that the subject has tested in the computer test of SART
3
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Description
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affect
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Timepoint
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Before and after each stimulation session
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Method of measurement
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the score that the subject achieves on the PANAS positive and negative emotion scale.
Secondary outcomes
1
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Description
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Side effects of tDCS: Headache, dizziness, burning, itching
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Timepoint
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Immediately after the actual stimulation and sham condition
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Method of measurement
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TDCS Side Effects Questionnaire
Intervention groups
1
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Description
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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)
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Category
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Diagnosis
2
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Description
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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)
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Category
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Diagnosis
3
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Description
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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
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Category
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Diagnosis
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable