Comparison of the effectiveness of traditional and multichannel direct cranial stimulation (tDCS) and Sham tDCS on depressive symptoms, working memory in patients with cognitive flexibility, response inhibition, domain decision making, QEEG asymmetry regulation in patients with major depressive disorder
Design
A randomized, double-blind, randomized controlled clinical trial of 60 patients
Settings and conduct
This study will be performed in Beheshti Hospital clinic with transcranial stimulation method for 20 sessions.
Participants/Inclusion and exclusion criteria
Having unipolar MDD diagnostic criteria based on (DSM-5) based on psychiatrist diagnosis and with psychological interview
Do not take antidepressants now or have a regular medication regimen for the past 4 weeks. Number 17 on the Hamilton Depression Inventory .Exclusion criteria:Diagnosis of bipolar disorder Diagnosis of substance use or alcohol Detection of dementia Diagnosis of personality disorder.Diagnosis of brain injury, stroke or brain tumor.Existence or history of psychosis.Diagnosis of epilepsy or history of loss of consciousness
Intervention groups
Traditional transcranial stimulation: The anode is in the left dorsal prefrontal cortex (DLPFC) region (F3) and the cathode is in the right DLPFC region (F4) for 30 minutes and 20 days.
Multichannel transcranial stimulation: It occurs in several networks of the brain for 30 minutes and 20 days.
Control group: One of the significant points in clinical trials is the need for methods in which the degree of bias is minimized. In the protocols of the control group, the traditional transcranial stimulation method is used for this purpose.
Main outcome variables
Clinical signs of major depression; Executive function of people with major depression; Amplitude and coherence and asymmetry in the forehead cortex of people with major depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210517051330N1
Registration date:2021-06-20, 1400/03/30
Registration timing:prospective
Last update:2021-06-20, 1400/03/30
Update count:0
Registration date
2021-06-20, 1400/03/30
Registrant information
Name
marzieh abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4001
Email address
marziehabdi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Optimization of transcranial stimulation protocol with direct flow on executive functions and reduction of symptoms in people with major depression
Public title
Comparison of the effectiveness of traditional transcranial stimulation with multichannel extracranial stimulation on improving the clinical symptoms of people with major depression and improving their executive function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria for unipolar MDD based on psychiatrist diagnosis and clinical interview
Age range between 75-18 years
Failure to treat with at least one antidepressant
Do not take antidepressants now or have a consistent medication regimen for the past 4 weeks
Score 17 on the Hamilton Depression Inventory
Willingness to participate in research
Conscious consent to participate in research
Have the opportunity to participate in evaluation and treatment sessions (daily) (in terms of distance, cost, etc.)
Exclusion criteria:
Diagnosis of bipolar disorder
Diagnosis of substance use or alcohol
Detection of dementia
Diagnosis of personality disorder
Diagnosis of brain injury, stroke or brain tumor
Existence or history of psychosis
Diagnosis of epilepsy or history of loss of consciousness
Pregnancy
Contraindications to the use of tDCS (cranial plates), such as those using a pacemaker.
Currently or in the last 4 weeks the person has received another treatment for MDD (medication or other psychological treatments)
Having diseases related to the scalp
Having a history of head trauma and the presence of a device or tools in the head
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization unit: individual
Randomization tool: Random number table
How to make: First, the list of names of all members is obtained, then a score or number is assigned to each of them, and the required number is selected using a table of random numbers.
Hiding: Using sealed envelopes in random order.
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects do not know the type of intervention.
The patient receives the intervention in separate coded treatment rooms.
No mirrors are installed on the patient's entrance and exit.
Coding is done by one of the design partners.
Patients do not see each other during the intervention.
People who analyze the results do not know the nature of the study groups.
The evaluation is done by someone other than the researcher.
Placebo
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
Azadegan Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
IR.ZUMS.REC.1400.059
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
Percentage of people whose Beck questionnaire score is above 20
Timepoint
Measurement of depression before the intervention, in the tenth session of the intervention, after the intervention, one-month follow-up and three months after the intervention
Method of measurement
Beck Questionnaire
2
Description
Percentage of people whose Hamilton questionnaire score is above 17
Timepoint
Measurement before intervention, after the intervention, one-month follow-up and three months after the intervention
Method of measurement
Hamilton Depression Test
3
Description
Depression Score on the Montgomery–Åsberg Depression Rating Scale
Timepoint
Measurements before the intervention, after the intervention.one-month follow-up and three months after the intervention
Method of measurement
Montgomery–Åsberg Depression Rating Scale
4
Description
Cognitive test score in cantab test
Timepoint
Measurements before the intervention, after the intervention.one-month follow-up and three months after the intervention
Method of measurement
cantab test
5
Description
Analyze the electroencephalography results
Timepoint
Measurements before the intervention, after the intervention
Method of measurement
Electroencephalography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Traditional transcranial stimulation, in the treatment of direct current stimulation from the skull, two electrodes, one positive pole and the other negative pole, are placed on the head through a sponge pad soaked in conductive solution. Electric current by these electrodes reaches the surface of the cerebral cortex after passing through different areas (scalp, skull). The current that reaches this area charges the neurons with electricity and causes a positive and a negative pole, which leads to a change in the activity of that area.
Category
Treatment - Devices
2
Description
Intervention group: Intervention group: Group 2: Multichannel transcranial stimulation: Similar to the traditional method, except that smaller electrodes are used to stimulate networks and not just brain areas. Star Stim device is a combined electrical stimulation device with tape It is a brain that has 8 channels. This device has a cap that has designed 39 positions based on the 10-10 system to place the electrodes on the head. The electrodes include dry and wet gel carriers for electroencephalography, electrodes in different sizes for stimulation and combined electrodes, as well as reference electrodes. The software is related to this NIC device, which allows us to do so. Let us have an anodal study and also be able to include the sham group or the double-blind method in our studies.In this study, the stimulation is for 20 sessions of 30 minutes.
Category
Treatment - Devices
3
Description
Control group: Control group: A method to reduce bias in clinical trials that use brain stimulation therapies such as the traditional transcranial stimulation method. It is based on imitation of the same main treatment. Its duration is 30 minutes in the form of 30 seconds of ramp-up, 30 seconds of stimulation, 30 seconds of ramp down.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital Clinic
Full name of responsible person
Marzieh Abdi
Street address
Ark Square. Shahid Beheshti Therapeutic and Psychiatric Education Center
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
Marziehabdi@zums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Behzad Peyda
Street address
Ark Square .Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3315 6141
Fax
+98 24 3354 2403
Email
Marziehabdi@zums.ac.ir
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
Marzieh Abdi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Square. Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 922 486 3706
Fax
+98 24 3354 2403
Email
Marziehabdi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Marzieh Abdi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Square. Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
Marziehabdi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Marzieh Abdi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Square. Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
33542403
Phone
+98 24 3354 4001
Email
Marziehabdi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Outcomes and results are published in the form of statistics
When the data will become available and for how long
After publishing the article
To whom data/document is available
The data will be available to researchers
Under which criteria data/document could be used
Can be used for secondary studies
From where data/document is obtainable
marziehabdi@zums.ac.ir
09224863706
What processes are involved for a request to access data/document